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Otosclerosis surgery: Assessment of patient comfort
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Original article
Otosclerosis surgery: Assessment of patient comfort C.-E. Rouf a,b,∗ , D. Bakhos a,b , J.-B. Riou a , S. Morinière a,b , E. Lescanne a,b a b
Service ORL et chirurgie cervico-faciale, CHRU de Tours, 2, boulevard Tonnellé, 37000 Tours, France Faculté de Médecine, université Franc¸ois-Rabelais de Tours, 20, boulevard Tonnellé, 37000 Tours, France
a r t i c l e
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Keywords: Local anesthesia Otosclerosis Stapedotomy Postoperative stress Quality of life
a b s t r a c t Objectives: To evaluate operative comfort and stress in patients undergoing stapedotomy for otosclerosis under local versus general anesthesia. Material and methods: Consecutive otosclerosis patients managed over a 9-month period responded to 3 validated questionnaires to assess peri- and post-operative comfort: Glasgow Benefit Inventory, Cohen’s Perceived Stress Scale and the Posttraumatic Stress Disorder Checklist Scale. These results and audiometric data were compared between local and general anesthesia groups. Results: Twenty-one patients were included in the local anesthesia group and 7 in the general anesthesia group, after exclusion of patients with history of otosclerosis surgery. There was no significant intergroup difference on Glasgow Benefit Inventory (P = 0.38) or Posttraumatic Stress Disorder Checklist Scale (P = 0.86). Perceived Stress Scale scores were higher in the general anesthesia group (P = 0.038). In total, 67% of patients reported no discomfort under local anesthesia, and 86% were ready to undergo the procedure under local anesthesia again. There were no significant differences in postoperative symptoms, or in air-bone gap ≤ 10 dB (local anesthesia 81%, general anesthesia 71%; P = 0.156). Conclusions: Local anesthesia in otosclerosis surgery did not increase stress or postoperative symptoms compared to general anesthesia. Audiometric results were not affected by type of anesthesia. © 2019 Published by Elsevier Masson SAS.
1. Introduction Surgery under local anesthesia (LA) enhanced by conscious sedation as an alternative to general anesthesia (GA) is a subject of debate in the otology community [1]. Anesthesia needs to create optimal conditions for both surgeon and patient: blood-free operative site, precise head positioning, and good respiration [2]. LA has certain advantages: avoiding the risks inherent to GA, and lower cost [2–5]. Surgery under LA scheduled on an outpatient basis is well adapted to current policies of reducing hospital stay costs. The main arguments against it concern the patient’s discomfort and the risk of sudden movements. It is suited to short reproducible scheduled procedures in cooperative patients [2], but not to long or unusual procedures scheduled in anxious patients or children [2]. Thus, tympanoplasty, mastoidectomy, myringoplasty, cochlear implantation and ossiculoplasty are eligible for enhanced LA [6–8]. Our experience in a series of 20 patients undergoing cochlear implantation confirmed good tolerance of the procedure conducted under LA [3].
∗ Corresponding author: Service ORL et chirurgie cervico-faciale, CHRU de Tours, 2, boulevard Tonnellé, 37000 Tours, France. E-mail address: [email protected] (C.-E. Rouf).
Laser stapedotomy for otosclerosis is suited to LA, being short, standardized and reproducible [9]. Anesthetization of the ear by lidocaine injection abolishes painful sensitivity around the operative site. Sedation by midazolam and sufentanil calms the patient’s stress and anxiety [1]. Wegner et al. demonstrated that there was no significant difference in functional results (air-bone gap, severe sensorineural hearing loss or dizziness) for the procedure conducted under GA versus LA [8]. As well as functional outcome, patient comfort is a criterion of treatment success. Subramaniam et al., in a series of 35 patients undergoing stapes surgery, reported improved postoperative quality of life [10]. Surgical stress in stapes surgery, however, has never been reported as a quality-of-life indicator. The main objective of the present study was to compare operative comfort and stress in otosclerosis surgery under LA versus GA. The secondary objective was to compare functional results.
2. Material and methods A single-center retrospective study conducted over a 9-month period compared laser stapedotomy between LA enhanced by intravenous sedation and GA. The main endpoint was peri- and post-operative comfort.
https://doi.org/10.1016/j.anorl.2019.10.014 1879-7296/© 2019 Published by Elsevier Masson SAS.
Please cite this article in press as: Rouf C-E, et al. Otosclerosis surgery: Assessment of patient comfort. European Annals of Otorhinolaryngology, Head and Neck diseases (2019), https://doi.org/10.1016/j.anorl.2019.10.014
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A consecutive series of 65 patients aged over 18 years, operated on for otosclerosis, included all first-line procedures. Exclusion criteria comprised surgical revision and previous contralateral procedure. CO2 laser stapedotomy was performed by 2 otologists, on a minimal intra-aural approach or by speculum. The technique was standardized: laser crurotomy and stapedotomy (AcuPulse CO2 Laser, Lumenis) with MatriX® (Kurz) or Fish® (Gyrus) transstapes piston to restore columella effect. Surgery was performed either under GA or under LA enhanced by intravenous sedation, the patient choosing the type of anesthesia during the preoperative information session. In GA, induction used 2–2.5 mg propofol per kg body-weight and remifentanil or sufentanil in target-controlled intravenous anesthesia. Maintenance used continuous target-controlled propofol and remifentanil perfusion. An intravenous anti-emetic was administered at start (dexamethasone and/or droperidol) and end of procedure (ondansetron). In LA, 1% lidocaine with 1:100,000 epinephrine was injected in the approach after skin antisepsis applied to the ear and ear canal. The injection was repeated under microscopy control after the sterile drapes were positioned, leaving access to the head open to prevent claustrophobia. The approach injection was associated to intravenous sedation and analgesia, supervised by the anesthesiologist following our department’s monitored anesthesia care protocol, as previously described [1,3]. Perioperative monitoring was standard: electrocardiography, pulsed oximetry, and non-invasive blood-pressure monitoring. Oxygen was supplied at 2–3 L/min by nasal cannula. Low-dose midazolam (0.5–1 mg) and sufentanil (2.5–5 g) were administered intravenously, with supplementary boli of similar dose adjusted to patient comfort. Droperidol 0.625 mg was administered as prophylactic anti-emetic at start of procedure. Peri- and postoperative comfort was assessed by questionnaires 1 month postoperatively. Study endpoints comprised pain on visual analog scale (VAS) and validated self-administered questionnaire results: Glasgow Benefit Inventory (GBI) for quality of life [11], Cohen’s Perceived Stress Scale (PSS) [12,13], and Posttraumatic Stress Disorder Checklist Scale (PCLS) [14,15]. GBI is a generic and specific retrospective quality of life scale for otorhinolaryngological surgery [16], comprising 18 questions on 5-point Likert scales: 1 = clear deterioration in quality of life; 3 = no change; 5 = clear improvement. The total score is calculated out of 100. PSS assesses perceived stress generically rather than specifically [12]. It comprises 10 items on a 5-point scale: 1 = never to 5 = often
or, conversely, for items 33, 34, 36 and 37 5 = never to 1 = often [12,13]. PCLS is a post-traumatic stress disorder (PTSD) screening instrument [14,15] comprising 17 items scored 1 to 5 according to symptom intensity and frequency. Results were interpreted as follows: • GBI: score < 60 = impaired quality of life; • PSS: score ≥ 40 = pathological stress; • PCLS: score ≥ 44 = PTSD. Audiometry was performed under standardized conditions, in a soundproof booth with equipment calibrated according to ISO 8253-1:2010: Madsen Astera® audiometer using Otosuite® software (GN Otometrics, Denmark). The supra-aural headset was TDH-39® (Telephonics, USA) and the bone transducers B-81® (Radioear, USA). Audiometry was performed preoperatively and at 3–6 months. Data were analyzed following AAOHNS guidelines [17]: mean threshold at 0.5, 1, 2 and 3 kHz on air conduction and on bone conduction, and postoperative air-bone gap (ABG); ABG ≤ 10 dB indicates success, and ≥ 15 dB bone conduction threshold loss indicates severe sensorineural hearing loss [17–20]. Results were presented graphically on Amsterdam Hearing Evaluation Plots [18,21]. In the LA and GA groups, qualitative variables were reported as number and percentage and compared on Fisher exact test; qualitative variables were reported as mean and standard deviation and compared on non-parametric Mann–Whitney test due to small sample size. Audiometry data were analyzed in Wilcoxon signed ranks test. The significance threshold was set at P ≤ 0.05. The study had local review board approval (No. 2017064). 3. Results Fifty-three of the 65 patients operated on during the study period on agreed to participate, and 28 met the inclusion criteria. The 25 patients excluded had already had contralateral surgery or were undergoing surgical revision. Twenty-one patients chose LA and 7 chose GA. All underwent immediate postoperative pure-tone bone conduction audiometry or Weber acoumetry; there were no cases of severe sensorineural hearing loss. The Table 1 shows preoperative data for the 2 groups, which were comparable for gender (P = 0.371, OR = 0.28, 95% CI = 0.005–3.1), age (P = 0.791), operated side (P = 0.191, OR = 5.2, 95% CI = 0.5–275) and audiometric parameters.
Table 1 Preoperative characteristics of patients undergoing laser stapedotomy.
Number of patients included Mean age (range) Gender (% female) Side (% left) Mean hearing threshold (dB) Bone conduction Air conduction Air-bone gap Mean thresholds per frequency (dB) Bone conduction 0.5 kHz Bone conduction 1 kHz Bone conduction 2 kHz Bone conduction 3 kHz Air conduction 0.5 kHz Air conduction 1 kHz Air conduction 2 kHz Air conduction 3 kHz
General anesthesia
Local anesthesia
OR (95% CI)
P
U
7 44.7 ± 15.3 (62–18) 86 14
21 47.8 ± 11.1 (65–29) 62 48
0.791 0.371 0.191
79
0.28 (0.005–3.1) 5.17 (0.5–275)
30.6 ± 11.3 58.2 ± 18.0 27.6 ± 11.8
25.4 ± 7.0 52.3 ± 11.4 26.9 ± 11.6
0.211 0.472 0.958
49.5 59.5 72
23.6 ± 12.1 30.0 ± 12.2 37.1 ± 15.0 31.8 ± 12.4 65.0 ± 15.8 62.9 ± 18.9 55.7 ± 19.7 49.3 ± 20.9
21.4 ± 12.8 23.8 ± 8.8 30.5 ± 8.4 25.8 ± 7.2 60.2 ± 13.2 57.9 ± 13.6 47.1 ± 13.6 43.8 ± 11.5
0.503 0.194 0.306 0.229 0.647 0.605 0.272 0.707
60.5 49 54 50.5 64.5 63.5 52.5 66
OR: odds ratio; CI: confidence interval.
Please cite this article in press as: Rouf C-E, et al. Otosclerosis surgery: Assessment of patient comfort. European Annals of Otorhinolaryngology, Head and Neck diseases (2019), https://doi.org/10.1016/j.anorl.2019.10.014
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3.1. Peri- and postoperative symptoms
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GA patients (P = 1). No patients showed pathological postoperative stress (PSS < 40) or PTSD (PCLS < 44).
LA patients were able to report their experience during surgery. Pain on VAS was 1 ± 1.5, with 67% of patients feeling no discomfort. Tinnitus, uncomfortable position or anxiety were in all reported by 5% of patients, and dizziness and nausea by 24% and 14% respectively. None reported dyspnea or pain. In total, 86% would be prepared to have ENT surgery under LA again, and 86% would recommend it to a friend. The Table 2 shows postoperative symptoms, with no significant difference between LA and GA.
3.2. Postoperative stress and quality of life The Table 2 shows questionnaire scores. There were no significant inter-group differences on GBI (P = 0.38) or PCLS (P = 0.86), while PSS scores were significantly higher in GA (P = 0.038). Quality of life was impaired (GBI < 60) in 2 LA patients (10%) and no
3.3. Hearing assessment The Table 3 shows audiometric data, and individual progression is shown in Figs. 1 and 2. Hearing thresholds improved significantly except for bone conduction at 1 kHz and air conduction at 2 and 3 kHz in LA and bone conduction at 0.5 kHz in GA. Air-bone gap closure was comparable between groups. There were no cases of severe sensorineural hearing loss. There were no significant intergroup differences in mean postoperative air-bone gap (GA, 8.3; LA, 5.9; P = 0.335), air-conduction threshold (28.9 and 26.5; P = 0.470) or bone-conduction threshold (19.8 and 20.6; P = 0.979) or rates of postoperative ABG < 10 dB (71% and 81%; P = 0.622). In Fig. 1, data points below the full diagonal line represent patients with overclosure: 10 in LA and 6 in GA (P = 0.18, OR = 0.16,
Table 2 Surgical stress and postoperative symptoms in.
Mean pain on VAS Complaint (%) None Pain Vertigo Uncomfortable position Tinnitus Nausea Anxiety Mean scores GBI PSS PCLS Satisfaction (%) GBI > 60 PSS < 40 PCLS < 44
General anesthesia
Local anesthesia
P
1.4 ± 2.2
1.0 ± 1.5
0.783
57 14 14 0 0 14 0
67 0 24 5 5 14 5
0.674 0.25 1 1 1 1 1
70.7 ± 5.8 20.4 ± 1.7 19.7 ± 3.8
68 ± 6.8 17.2 ± 5.6 18.7 ± 2.8
0.38 0.038 0.86
100 100 100
90 100 100
1 1 1
OR (95% CI)
1.5 (0.2–11.7) 1.8 (0.2–103)
1 (0.06–61.1)
56.5 34 70
VAS: visual analog scale.
Table 3 Audiometric data: local and general anesthesia.
Local anesthesia Mean thresholds (dB) Bone conduction Air conduction Air-bone gap Mean thresholds per frequency (dB) Bone conduction 0.5 kHz Bone conduction 1 kHz Bone conduction 2 kHz Bone conduction 3 kHz Air conduction 0.5 kHz Air conduction 1 kHz Air conduction 2 kHz Air conduction 3 kHz General anesthesia Mean thresholds (dB) Bone conduction Air conduction Air-bone gap Mean thresholds per frequency (dB) Bone conduction 0.5 kHz Bone conduction 1 kHz Bone conduction 2 kHz Bone conduction 3 kHz Air conduction 0.5 kHz Air conduction 1 kHz Air conduction 2 kHz Air conduction 3 kHz
Preoperative
Postoperative
P
U
30.6 ± 11.3 58.2 ± 18 27.6 ± 11.8
19.8 ± 26.8 28.9 ± 7.5 8.3 ± 5.7
0.022 0.016 0.031
28 28 27
± ± ± ± ± ± ± ±
0.02 0.27 0.04 0.04 0.02 0.02 0.22 0.22
28 12 21 21 28 28 28 28
0.003 0.00006 0.00006
184 231 231
0.08 0.01 0.0009 0.02 0.00008 0.00006 0.00006 0.00006
125.5 140 131 167 229 231 231 231
23.6 30 37.1 31.8 65 62.9 55.7 49.3
± ± ± ± ± ± ± ±
12.1 12.1 15 12.4 15.8 18.9 19.7 20.9
25.4 ± 7 52.3 ± 11.4 26.9 ± 11.6 21.4 23.8 30.5 25.8 60.2 57.9 47.1 43.8
± ± ± ± ± ± ± ±
12.8 8.8 8.4 7.2 13.2 13.6 13.6 11.5
13.6 25.7 25 18.1 25.7 32.1 30 38.7
11.4 8.4 12.2 10.6 3.5 9.9 11.5 19.9
20.6 ± 7.1 26.5 ± 8.7 5.9 ± 4.5 17.9 18.8 23.1 22.7 29 27.1 26.2 23.8
± ± ± ± ± ± ± ±
12.7 8.6 8.4 8.3 11.9 9.0 10.1 10.0
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Fig. 1. Amsterdam hearing evaluation plot. Each triangle or circle represents 1 case (GA: triangles; LA; circles). Full diagonal line: total ABG closure. Area between lines: success (ABG ≤ 10 dB). Area under full diagonal line: surgical success with overclosure.
Fig. 2. Amsterdam hearing evaluation plot. Each triangle or circle represents 1 case (GA: triangles; LA; circles). Area between lines: no bone conduction gain exceeding 10 dB. Points below lower diagonal: bone conduction gain ≥ 10 dB.
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95% CI = 0.003–1.7). Points between the two diagonals represent success, without overclosure: 6 in LA and none in GA (P = 0.29). In Fig. 2, data points below the full diagonal line represent patients with ≥ 10 dB improvement in mean bone-conduction threshold: 6 in LA and 5 in GA (P = 0.076, OR = 0.1, 95% CI = 0.013–1.4). Points above the dotted diagonal represent patients with ≥ 10 dB impairment: 1 in LA, none in GA (P = 1).
4. Discussion The present retrospective study compared stress following otosclerosis surgery according to LA versus GA. Quality of life, stress and post-traumatic stress were assessed on 3 self-administered questionnaires. GBI results showed no significant difference between groups, with identical quality of life. Quality of life improved in 100% of GA and 90% of LA patients. Stress is defined as an adaptation reaction to any stimulation, and is measured on the PSS. Post-traumatic stress corresponds to a traumatic event constantly re-lived and avoided, and is measured on the PCLS. There was no significant inter-group difference in PCLS score. Introducing a trans-stapes piston under LA did not induce general or post-traumatic stress. PSS score was lower in LA, which thus was less stressful than GA in the present series. None of the present patients showed post-traumatic or pathological stress. To our knowledge, there have been no previous assessments of stress induced by ENT surgery under LA. Zemmoura et al. assessed stress induced by low-grade glioma resection [22] in a prospective study of craniotomy under hypnosis and sedation; out of 25 patients, 1 showed post-traumatic stress and 7 showed pathological stress on PSS and PCLS [12–15]. Vertigo is a frequent and disabling postoperative symptom. The present rates were 24% in LA and 14% in GA. Motta et al., found no postoperative vertigo after 282 CO2 laser stapedotomies [23]. The present perioperative rates were higher, partly due to the definition of vertigo, Motta et al. counting only “severe” persistent vertigo [23] whereas we counted immediate postoperative vertigo reported by the patient. Postoperative pain was not worse with LA: mean VAS score was 1, which is low, testifying to good pain control. In total, 67% of LA patients reported no intraoperative discomfort, and none reported postoperative pain. Only 5% complained about operative positioning, 5% reported tinnitus and 14% nausea, all of which are satisfactorily low rates; even so, these symptoms had been targeted by analgesics and intravenous anti-emetics. Mean intraoperative pain on VAS was also very low, confirming satisfaction with LA. Isolated LA without sedation is classically the solution of choice for elderly patients with comorbidity. It may, however, entail pain and anxiety, with risk of cardiac ischemia by elevated blood pressure and heart rate [1]. LA enhanced by a sedative (benzodiazepine) and analgesic (opioid) on an anesthesia care monitoring protocol limits such risk. The low doses used have little respiratory depression effect, and droperidol has not only anti-emetic but sedative action, which is welcome in otology. These drugs, on the other hand, require specialized anesthesiological supervision and postoperative surveillance. The protocol shortens procedural time, requiring no induction, intubation, awakening and extubation. It does not, however, affect budgeting under the French health system. Audiometry showed significant improvement in bone and air conduction thresholds and air-bone gap in both groups, excepting bone conduction at 1 kHz and air conduction at 2 and 3 kHz in LA and bone conduction at 0.5 kHz in GA. Bittermann et al., in a series of 666 stapes procedures, likewise found significant improvement in air conduction thresholds [24], but not in bone conduction at 500
5
or 1000 Hz; the improvement in bone conduction was attributed to overclosure [25]. In the present series, there were no significant inter-group differences in audiometry. Wegner et al., analyzing 257 studies of otosclerosis surgery, found no significant difference between LA and GA for postoperative ABG ≤ 10 dB [8]. In the present study, individual functional results were reported on Amsterdam Hearing Evaluation Plots (AHEPs). This technique, described by De Bruijn et al., standardizes the presentation of audiometric results according to the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery [21]. In Fig. 1, it can be seen that 10 LA patients (48%) and 6 GA patients (86%) had results below the lower diagonal: i.e., surgical success with overclosure. De Bruijn et al. reported a similar rate, although the overclosure rate was better in the present study. In Fig. 2, it can be seen that 6 LA patients (29%) and 5 GA patients (71%) had results below the lower diagonal: i.e., bone conduction gain > 10 dB); 1 AL patient (5%) lay above the upper diagonal: i.e., deterioration in bone conduction. De Bruijn et al. reported that 15.1% of patients had bone conduction gain > 10 dB, lower than in the present series, and that only 2.2% showed > 10 dB deterioration in bone conduction threshold [21]. 5. Conclusion In the present study, otosclerosis surgery under enhanced LA did not induce greater post-traumatic stress than surgery under GA, and postoperative stress was lower. Postoperative quality of life was identical in both groups, as were audiometric results. Enhanced LA thus seems to be the solution of choice in laser stapedotomy for otosclerosis. Disclosure of interest The authors declare that they have no competing interest. References [1] Alzahrani M, Martin F, Bobillier C, Robier A, Lescanne E. Combined local anesthesia and monitored anesthesia care for cochlear implantation. Eur Ann Otorhinolaryngol Head Neck Dis 2014;131(4):261–2. [2] Liang S, Irwin MG. Review of anesthesia for middle ear surgery. Anesthesiol Clin 2010;28:519–28. [3] Pateron B, Bakhos D, LeLouarn A, Bordure P, Bozorg Grayeli A, Godey B, et al. Local anaesthesia and conscious sedation for cochlear implantation: experience with 20 patients. J Laryngol Otol 2016;130(2):151–6. [4] Greenberg MF, Pollard ZF. Adult strabismus surgery under propofol sedation with local versus general anesthesia. J AAPOS 2003;7:116–20. [5] GALA Trial Collaborative Group, Lewis SC, Warlow CP, Bodenham AR, Colam B, Rothwell PM, et al. General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multi- centre, randomised controlled trial. Lancet 2008;372:2132–42. [6] Yung MW. Local anaesthesia in middle ear surgery: survey of patients and surgeons. Clin Otolaryngol Allied Sci 1996;21(5):404–8. [7] Caner G, Olgun L, Gultekin G, et al. Local anesthesia for middle ear surgery. Otolaryngol Head Neck Surg 2005;133(2):295–7. [8] Wegner I, Bittermann AJ, Zinsmeester MM, Van der Heijden GJ, Grolman W. Local versus general anesthesia in stapes surgery for otosclerosis: a systematic review of the evidence. Otolaryngology – Head and Neck Surgery 2013;149(3):360–5. [9] Lescanne E, Moriniere S, Gohler C, Manceau A, Beutter P, Robier A. Retrospective case study of carbon dioxide laser stapedotomy with lens-based and mirrorbased micromanipulators. J Laryngol Otol 2003;117(4):256–60. [10] Subramaniam K, Eikelboom RH, Marino R, Atlas MD, Rajan GP. Patient’s quality of life and hearing outcomes after stapes surgery. Clin Otolaryngol 2006;31(4):273–9. [11] Hendry J, Chin A, Swan IR, Akeroyd MA, Browning GG. The Glasgow Benefit Inventory: a systematic review of the use and value of an otorhinolaryngological generic patient-recorded outcome measure. Clin Otolaryngol 2016;41(3):259–75. [12] Bellinghausen L, Collange J, Botella M, EmeryJL, Albert E. Factorial validation of the French scale for perceived stress in the workplace [in French]. Sante Publique 2009;21(4):365–73.
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Original article
Otosclerosis surgery: Assessment of patient comfort C.-E. Rouf a,b,∗ , D. Bakhos a,b , J.-B. Riou a , S. Morinière a,b , E. Lescanne a,b a b
Service ORL et chirurgie cervico-faciale, CHRU de Tours, 2, boulevard Tonnellé, 37000 Tours, France Faculté de Médecine, université Franc¸ois-Rabelais de Tours, 20, boulevard Tonnellé, 37000 Tours, France
a r t i c l e
i n f o
Keywords: Local anesthesia Otosclerosis Stapedotomy Postoperative stress Quality of life
a b s t r a c t Objectives: To evaluate operative comfort and stress in patients undergoing stapedotomy for otosclerosis under local versus general anesthesia. Material and methods: Consecutive otosclerosis patients managed over a 9-month period responded to 3 validated questionnaires to assess peri- and post-operative comfort: Glasgow Benefit Inventory, Cohen’s Perceived Stress Scale and the Posttraumatic Stress Disorder Checklist Scale. These results and audiometric data were compared between local and general anesthesia groups. Results: Twenty-one patients were included in the local anesthesia group and 7 in the general anesthesia group, after exclusion of patients with history of otosclerosis surgery. There was no significant intergroup difference on Glasgow Benefit Inventory (P = 0.38) or Posttraumatic Stress Disorder Checklist Scale (P = 0.86). Perceived Stress Scale scores were higher in the general anesthesia group (P = 0.038). In total, 67% of patients reported no discomfort under local anesthesia, and 86% were ready to undergo the procedure under local anesthesia again. There were no significant differences in postoperative symptoms, or in air-bone gap ≤ 10 dB (local anesthesia 81%, general anesthesia 71%; P = 0.156). Conclusions: Local anesthesia in otosclerosis surgery did not increase stress or postoperative symptoms compared to general anesthesia. Audiometric results were not affected by type of anesthesia. © 2019 Published by Elsevier Masson SAS.
1. Introduction Surgery under local anesthesia (LA) enhanced by conscious sedation as an alternative to general anesthesia (GA) is a subject of debate in the otology community [1]. Anesthesia needs to create optimal conditions for both surgeon and patient: blood-free operative site, precise head positioning, and good respiration [2]. LA has certain advantages: avoiding the risks inherent to GA, and lower cost [2–5]. Surgery under LA scheduled on an outpatient basis is well adapted to current policies of reducing hospital stay costs. The main arguments against it concern the patient’s discomfort and the risk of sudden movements. It is suited to short reproducible scheduled procedures in cooperative patients [2], but not to long or unusual procedures scheduled in anxious patients or children [2]. Thus, tympanoplasty, mastoidectomy, myringoplasty, cochlear implantation and ossiculoplasty are eligible for enhanced LA [6–8]. Our experience in a series of 20 patients undergoing cochlear implantation confirmed good tolerance of the procedure conducted under LA [3].
∗ Corresponding author: Service ORL et chirurgie cervico-faciale, CHRU de Tours, 2, boulevard Tonnellé, 37000 Tours, France. E-mail address: [email protected] (C.-E. Rouf).
Laser stapedotomy for otosclerosis is suited to LA, being short, standardized and reproducible [9]. Anesthetization of the ear by lidocaine injection abolishes painful sensitivity around the operative site. Sedation by midazolam and sufentanil calms the patient’s stress and anxiety [1]. Wegner et al. demonstrated that there was no significant difference in functional results (air-bone gap, severe sensorineural hearing loss or dizziness) for the procedure conducted under GA versus LA [8]. As well as functional outcome, patient comfort is a criterion of treatment success. Subramaniam et al., in a series of 35 patients undergoing stapes surgery, reported improved postoperative quality of life [10]. Surgical stress in stapes surgery, however, has never been reported as a quality-of-life indicator. The main objective of the present study was to compare operative comfort and stress in otosclerosis surgery under LA versus GA. The secondary objective was to compare functional results.
2. Material and methods A single-center retrospective study conducted over a 9-month period compared laser stapedotomy between LA enhanced by intravenous sedation and GA. The main endpoint was peri- and post-operative comfort.
https://doi.org/10.1016/j.anorl.2019.10.014 1879-7296/© 2019 Published by Elsevier Masson SAS.
Please cite this article in press as: Rouf C-E, et al. Otosclerosis surgery: Assessment of patient comfort. European Annals of Otorhinolaryngology, Head and Neck diseases (2019), https://doi.org/10.1016/j.anorl.2019.10.014
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A consecutive series of 65 patients aged over 18 years, operated on for otosclerosis, included all first-line procedures. Exclusion criteria comprised surgical revision and previous contralateral procedure. CO2 laser stapedotomy was performed by 2 otologists, on a minimal intra-aural approach or by speculum. The technique was standardized: laser crurotomy and stapedotomy (AcuPulse CO2 Laser, Lumenis) with MatriX® (Kurz) or Fish® (Gyrus) transstapes piston to restore columella effect. Surgery was performed either under GA or under LA enhanced by intravenous sedation, the patient choosing the type of anesthesia during the preoperative information session. In GA, induction used 2–2.5 mg propofol per kg body-weight and remifentanil or sufentanil in target-controlled intravenous anesthesia. Maintenance used continuous target-controlled propofol and remifentanil perfusion. An intravenous anti-emetic was administered at start (dexamethasone and/or droperidol) and end of procedure (ondansetron). In LA, 1% lidocaine with 1:100,000 epinephrine was injected in the approach after skin antisepsis applied to the ear and ear canal. The injection was repeated under microscopy control after the sterile drapes were positioned, leaving access to the head open to prevent claustrophobia. The approach injection was associated to intravenous sedation and analgesia, supervised by the anesthesiologist following our department’s monitored anesthesia care protocol, as previously described [1,3]. Perioperative monitoring was standard: electrocardiography, pulsed oximetry, and non-invasive blood-pressure monitoring. Oxygen was supplied at 2–3 L/min by nasal cannula. Low-dose midazolam (0.5–1 mg) and sufentanil (2.5–5 g) were administered intravenously, with supplementary boli of similar dose adjusted to patient comfort. Droperidol 0.625 mg was administered as prophylactic anti-emetic at start of procedure. Peri- and postoperative comfort was assessed by questionnaires 1 month postoperatively. Study endpoints comprised pain on visual analog scale (VAS) and validated self-administered questionnaire results: Glasgow Benefit Inventory (GBI) for quality of life [11], Cohen’s Perceived Stress Scale (PSS) [12,13], and Posttraumatic Stress Disorder Checklist Scale (PCLS) [14,15]. GBI is a generic and specific retrospective quality of life scale for otorhinolaryngological surgery [16], comprising 18 questions on 5-point Likert scales: 1 = clear deterioration in quality of life; 3 = no change; 5 = clear improvement. The total score is calculated out of 100. PSS assesses perceived stress generically rather than specifically [12]. It comprises 10 items on a 5-point scale: 1 = never to 5 = often
or, conversely, for items 33, 34, 36 and 37 5 = never to 1 = often [12,13]. PCLS is a post-traumatic stress disorder (PTSD) screening instrument [14,15] comprising 17 items scored 1 to 5 according to symptom intensity and frequency. Results were interpreted as follows: • GBI: score < 60 = impaired quality of life; • PSS: score ≥ 40 = pathological stress; • PCLS: score ≥ 44 = PTSD. Audiometry was performed under standardized conditions, in a soundproof booth with equipment calibrated according to ISO 8253-1:2010: Madsen Astera® audiometer using Otosuite® software (GN Otometrics, Denmark). The supra-aural headset was TDH-39® (Telephonics, USA) and the bone transducers B-81® (Radioear, USA). Audiometry was performed preoperatively and at 3–6 months. Data were analyzed following AAOHNS guidelines [17]: mean threshold at 0.5, 1, 2 and 3 kHz on air conduction and on bone conduction, and postoperative air-bone gap (ABG); ABG ≤ 10 dB indicates success, and ≥ 15 dB bone conduction threshold loss indicates severe sensorineural hearing loss [17–20]. Results were presented graphically on Amsterdam Hearing Evaluation Plots [18,21]. In the LA and GA groups, qualitative variables were reported as number and percentage and compared on Fisher exact test; qualitative variables were reported as mean and standard deviation and compared on non-parametric Mann–Whitney test due to small sample size. Audiometry data were analyzed in Wilcoxon signed ranks test. The significance threshold was set at P ≤ 0.05. The study had local review board approval (No. 2017064). 3. Results Fifty-three of the 65 patients operated on during the study period on agreed to participate, and 28 met the inclusion criteria. The 25 patients excluded had already had contralateral surgery or were undergoing surgical revision. Twenty-one patients chose LA and 7 chose GA. All underwent immediate postoperative pure-tone bone conduction audiometry or Weber acoumetry; there were no cases of severe sensorineural hearing loss. The Table 1 shows preoperative data for the 2 groups, which were comparable for gender (P = 0.371, OR = 0.28, 95% CI = 0.005–3.1), age (P = 0.791), operated side (P = 0.191, OR = 5.2, 95% CI = 0.5–275) and audiometric parameters.
Table 1 Preoperative characteristics of patients undergoing laser stapedotomy.
Number of patients included Mean age (range) Gender (% female) Side (% left) Mean hearing threshold (dB) Bone conduction Air conduction Air-bone gap Mean thresholds per frequency (dB) Bone conduction 0.5 kHz Bone conduction 1 kHz Bone conduction 2 kHz Bone conduction 3 kHz Air conduction 0.5 kHz Air conduction 1 kHz Air conduction 2 kHz Air conduction 3 kHz
General anesthesia
Local anesthesia
OR (95% CI)
P
U
7 44.7 ± 15.3 (62–18) 86 14
21 47.8 ± 11.1 (65–29) 62 48
0.791 0.371 0.191
79
0.28 (0.005–3.1) 5.17 (0.5–275)
30.6 ± 11.3 58.2 ± 18.0 27.6 ± 11.8
25.4 ± 7.0 52.3 ± 11.4 26.9 ± 11.6
0.211 0.472 0.958
49.5 59.5 72
23.6 ± 12.1 30.0 ± 12.2 37.1 ± 15.0 31.8 ± 12.4 65.0 ± 15.8 62.9 ± 18.9 55.7 ± 19.7 49.3 ± 20.9
21.4 ± 12.8 23.8 ± 8.8 30.5 ± 8.4 25.8 ± 7.2 60.2 ± 13.2 57.9 ± 13.6 47.1 ± 13.6 43.8 ± 11.5
0.503 0.194 0.306 0.229 0.647 0.605 0.272 0.707
60.5 49 54 50.5 64.5 63.5 52.5 66
OR: odds ratio; CI: confidence interval.
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3.1. Peri- and postoperative symptoms
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GA patients (P = 1). No patients showed pathological postoperative stress (PSS < 40) or PTSD (PCLS < 44).
LA patients were able to report their experience during surgery. Pain on VAS was 1 ± 1.5, with 67% of patients feeling no discomfort. Tinnitus, uncomfortable position or anxiety were in all reported by 5% of patients, and dizziness and nausea by 24% and 14% respectively. None reported dyspnea or pain. In total, 86% would be prepared to have ENT surgery under LA again, and 86% would recommend it to a friend. The Table 2 shows postoperative symptoms, with no significant difference between LA and GA.
3.2. Postoperative stress and quality of life The Table 2 shows questionnaire scores. There were no significant inter-group differences on GBI (P = 0.38) or PCLS (P = 0.86), while PSS scores were significantly higher in GA (P = 0.038). Quality of life was impaired (GBI < 60) in 2 LA patients (10%) and no
3.3. Hearing assessment The Table 3 shows audiometric data, and individual progression is shown in Figs. 1 and 2. Hearing thresholds improved significantly except for bone conduction at 1 kHz and air conduction at 2 and 3 kHz in LA and bone conduction at 0.5 kHz in GA. Air-bone gap closure was comparable between groups. There were no cases of severe sensorineural hearing loss. There were no significant intergroup differences in mean postoperative air-bone gap (GA, 8.3; LA, 5.9; P = 0.335), air-conduction threshold (28.9 and 26.5; P = 0.470) or bone-conduction threshold (19.8 and 20.6; P = 0.979) or rates of postoperative ABG < 10 dB (71% and 81%; P = 0.622). In Fig. 1, data points below the full diagonal line represent patients with overclosure: 10 in LA and 6 in GA (P = 0.18, OR = 0.16,
Table 2 Surgical stress and postoperative symptoms in.
Mean pain on VAS Complaint (%) None Pain Vertigo Uncomfortable position Tinnitus Nausea Anxiety Mean scores GBI PSS PCLS Satisfaction (%) GBI > 60 PSS < 40 PCLS < 44
General anesthesia
Local anesthesia
P
1.4 ± 2.2
1.0 ± 1.5
0.783
57 14 14 0 0 14 0
67 0 24 5 5 14 5
0.674 0.25 1 1 1 1 1
70.7 ± 5.8 20.4 ± 1.7 19.7 ± 3.8
68 ± 6.8 17.2 ± 5.6 18.7 ± 2.8
0.38 0.038 0.86
100 100 100
90 100 100
1 1 1
OR (95% CI)
1.5 (0.2–11.7) 1.8 (0.2–103)
1 (0.06–61.1)
56.5 34 70
VAS: visual analog scale.
Table 3 Audiometric data: local and general anesthesia.
Local anesthesia Mean thresholds (dB) Bone conduction Air conduction Air-bone gap Mean thresholds per frequency (dB) Bone conduction 0.5 kHz Bone conduction 1 kHz Bone conduction 2 kHz Bone conduction 3 kHz Air conduction 0.5 kHz Air conduction 1 kHz Air conduction 2 kHz Air conduction 3 kHz General anesthesia Mean thresholds (dB) Bone conduction Air conduction Air-bone gap Mean thresholds per frequency (dB) Bone conduction 0.5 kHz Bone conduction 1 kHz Bone conduction 2 kHz Bone conduction 3 kHz Air conduction 0.5 kHz Air conduction 1 kHz Air conduction 2 kHz Air conduction 3 kHz
Preoperative
Postoperative
P
U
30.6 ± 11.3 58.2 ± 18 27.6 ± 11.8
19.8 ± 26.8 28.9 ± 7.5 8.3 ± 5.7
0.022 0.016 0.031
28 28 27
± ± ± ± ± ± ± ±
0.02 0.27 0.04 0.04 0.02 0.02 0.22 0.22
28 12 21 21 28 28 28 28
0.003 0.00006 0.00006
184 231 231
0.08 0.01 0.0009 0.02 0.00008 0.00006 0.00006 0.00006
125.5 140 131 167 229 231 231 231
23.6 30 37.1 31.8 65 62.9 55.7 49.3
± ± ± ± ± ± ± ±
12.1 12.1 15 12.4 15.8 18.9 19.7 20.9
25.4 ± 7 52.3 ± 11.4 26.9 ± 11.6 21.4 23.8 30.5 25.8 60.2 57.9 47.1 43.8
± ± ± ± ± ± ± ±
12.8 8.8 8.4 7.2 13.2 13.6 13.6 11.5
13.6 25.7 25 18.1 25.7 32.1 30 38.7
11.4 8.4 12.2 10.6 3.5 9.9 11.5 19.9
20.6 ± 7.1 26.5 ± 8.7 5.9 ± 4.5 17.9 18.8 23.1 22.7 29 27.1 26.2 23.8
± ± ± ± ± ± ± ±
12.7 8.6 8.4 8.3 11.9 9.0 10.1 10.0
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Fig. 1. Amsterdam hearing evaluation plot. Each triangle or circle represents 1 case (GA: triangles; LA; circles). Full diagonal line: total ABG closure. Area between lines: success (ABG ≤ 10 dB). Area under full diagonal line: surgical success with overclosure.
Fig. 2. Amsterdam hearing evaluation plot. Each triangle or circle represents 1 case (GA: triangles; LA; circles). Area between lines: no bone conduction gain exceeding 10 dB. Points below lower diagonal: bone conduction gain ≥ 10 dB.
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95% CI = 0.003–1.7). Points between the two diagonals represent success, without overclosure: 6 in LA and none in GA (P = 0.29). In Fig. 2, data points below the full diagonal line represent patients with ≥ 10 dB improvement in mean bone-conduction threshold: 6 in LA and 5 in GA (P = 0.076, OR = 0.1, 95% CI = 0.013–1.4). Points above the dotted diagonal represent patients with ≥ 10 dB impairment: 1 in LA, none in GA (P = 1).
4. Discussion The present retrospective study compared stress following otosclerosis surgery according to LA versus GA. Quality of life, stress and post-traumatic stress were assessed on 3 self-administered questionnaires. GBI results showed no significant difference between groups, with identical quality of life. Quality of life improved in 100% of GA and 90% of LA patients. Stress is defined as an adaptation reaction to any stimulation, and is measured on the PSS. Post-traumatic stress corresponds to a traumatic event constantly re-lived and avoided, and is measured on the PCLS. There was no significant inter-group difference in PCLS score. Introducing a trans-stapes piston under LA did not induce general or post-traumatic stress. PSS score was lower in LA, which thus was less stressful than GA in the present series. None of the present patients showed post-traumatic or pathological stress. To our knowledge, there have been no previous assessments of stress induced by ENT surgery under LA. Zemmoura et al. assessed stress induced by low-grade glioma resection [22] in a prospective study of craniotomy under hypnosis and sedation; out of 25 patients, 1 showed post-traumatic stress and 7 showed pathological stress on PSS and PCLS [12–15]. Vertigo is a frequent and disabling postoperative symptom. The present rates were 24% in LA and 14% in GA. Motta et al., found no postoperative vertigo after 282 CO2 laser stapedotomies [23]. The present perioperative rates were higher, partly due to the definition of vertigo, Motta et al. counting only “severe” persistent vertigo [23] whereas we counted immediate postoperative vertigo reported by the patient. Postoperative pain was not worse with LA: mean VAS score was 1, which is low, testifying to good pain control. In total, 67% of LA patients reported no intraoperative discomfort, and none reported postoperative pain. Only 5% complained about operative positioning, 5% reported tinnitus and 14% nausea, all of which are satisfactorily low rates; even so, these symptoms had been targeted by analgesics and intravenous anti-emetics. Mean intraoperative pain on VAS was also very low, confirming satisfaction with LA. Isolated LA without sedation is classically the solution of choice for elderly patients with comorbidity. It may, however, entail pain and anxiety, with risk of cardiac ischemia by elevated blood pressure and heart rate [1]. LA enhanced by a sedative (benzodiazepine) and analgesic (opioid) on an anesthesia care monitoring protocol limits such risk. The low doses used have little respiratory depression effect, and droperidol has not only anti-emetic but sedative action, which is welcome in otology. These drugs, on the other hand, require specialized anesthesiological supervision and postoperative surveillance. The protocol shortens procedural time, requiring no induction, intubation, awakening and extubation. It does not, however, affect budgeting under the French health system. Audiometry showed significant improvement in bone and air conduction thresholds and air-bone gap in both groups, excepting bone conduction at 1 kHz and air conduction at 2 and 3 kHz in LA and bone conduction at 0.5 kHz in GA. Bittermann et al., in a series of 666 stapes procedures, likewise found significant improvement in air conduction thresholds [24], but not in bone conduction at 500
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or 1000 Hz; the improvement in bone conduction was attributed to overclosure [25]. In the present series, there were no significant inter-group differences in audiometry. Wegner et al., analyzing 257 studies of otosclerosis surgery, found no significant difference between LA and GA for postoperative ABG ≤ 10 dB [8]. In the present study, individual functional results were reported on Amsterdam Hearing Evaluation Plots (AHEPs). This technique, described by De Bruijn et al., standardizes the presentation of audiometric results according to the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery [21]. In Fig. 1, it can be seen that 10 LA patients (48%) and 6 GA patients (86%) had results below the lower diagonal: i.e., surgical success with overclosure. De Bruijn et al. reported a similar rate, although the overclosure rate was better in the present study. In Fig. 2, it can be seen that 6 LA patients (29%) and 5 GA patients (71%) had results below the lower diagonal: i.e., bone conduction gain > 10 dB); 1 AL patient (5%) lay above the upper diagonal: i.e., deterioration in bone conduction. De Bruijn et al. reported that 15.1% of patients had bone conduction gain > 10 dB, lower than in the present series, and that only 2.2% showed > 10 dB deterioration in bone conduction threshold [21]. 5. Conclusion In the present study, otosclerosis surgery under enhanced LA did not induce greater post-traumatic stress than surgery under GA, and postoperative stress was lower. Postoperative quality of life was identical in both groups, as were audiometric results. Enhanced LA thus seems to be the solution of choice in laser stapedotomy for otosclerosis. Disclosure of interest The authors declare that they have no competing interest. References [1] Alzahrani M, Martin F, Bobillier C, Robier A, Lescanne E. Combined local anesthesia and monitored anesthesia care for cochlear implantation. Eur Ann Otorhinolaryngol Head Neck Dis 2014;131(4):261–2. [2] Liang S, Irwin MG. Review of anesthesia for middle ear surgery. Anesthesiol Clin 2010;28:519–28. [3] Pateron B, Bakhos D, LeLouarn A, Bordure P, Bozorg Grayeli A, Godey B, et al. Local anaesthesia and conscious sedation for cochlear implantation: experience with 20 patients. J Laryngol Otol 2016;130(2):151–6. [4] Greenberg MF, Pollard ZF. Adult strabismus surgery under propofol sedation with local versus general anesthesia. J AAPOS 2003;7:116–20. [5] GALA Trial Collaborative Group, Lewis SC, Warlow CP, Bodenham AR, Colam B, Rothwell PM, et al. General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multi- centre, randomised controlled trial. Lancet 2008;372:2132–42. [6] Yung MW. Local anaesthesia in middle ear surgery: survey of patients and surgeons. Clin Otolaryngol Allied Sci 1996;21(5):404–8. [7] Caner G, Olgun L, Gultekin G, et al. Local anesthesia for middle ear surgery. Otolaryngol Head Neck Surg 2005;133(2):295–7. [8] Wegner I, Bittermann AJ, Zinsmeester MM, Van der Heijden GJ, Grolman W. Local versus general anesthesia in stapes surgery for otosclerosis: a systematic review of the evidence. Otolaryngology – Head and Neck Surgery 2013;149(3):360–5. [9] Lescanne E, Moriniere S, Gohler C, Manceau A, Beutter P, Robier A. Retrospective case study of carbon dioxide laser stapedotomy with lens-based and mirrorbased micromanipulators. J Laryngol Otol 2003;117(4):256–60. [10] Subramaniam K, Eikelboom RH, Marino R, Atlas MD, Rajan GP. Patient’s quality of life and hearing outcomes after stapes surgery. Clin Otolaryngol 2006;31(4):273–9. [11] Hendry J, Chin A, Swan IR, Akeroyd MA, Browning GG. The Glasgow Benefit Inventory: a systematic review of the use and value of an otorhinolaryngological generic patient-recorded outcome measure. Clin Otolaryngol 2016;41(3):259–75. [12] Bellinghausen L, Collange J, Botella M, EmeryJL, Albert E. Factorial validation of the French scale for perceived stress in the workplace [in French]. Sante Publique 2009;21(4):365–73.
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