Ultrasound guided versus fluroscopic guided pulsed radiofrequency therapy of the stellate ganglion in neuropathic pain: A prospective controlled comparative study

Ultrasound guided versus fluroscopic guided pulsed radiofrequency therapy of the stellate ganglion in neuropathic pain: A prospective controlled comparative study

The Egyptian Journal of Radiology and Nuclear Medicine 49 (2018) 71–75 Contents lists available at ScienceDirect The Egyptian Journal of Radiology a...

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The Egyptian Journal of Radiology and Nuclear Medicine 49 (2018) 71–75

Contents lists available at ScienceDirect

The Egyptian Journal of Radiology and Nuclear Medicine journal homepage: www.sciencedirect.com/locate/ejrnm

Original Article

Ultrasound guided versus fluroscopic guided pulsed radiofrequency therapy of the stellate ganglion in neuropathic pain: A prospective controlled comparative study Mohamed H. Shaaban b, Raafat M. Reyad a, Hossam Z. Ghobrial a, Rania H. Hashem b,⇑ a b

Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Egypt Department of Diagnostic and Interventional Radiology, Kasr El Aini, Faculty of Medicine, Cairo University, Egypt

a r t i c l e

i n f o

Article history: Received 24 January 2017 Accepted 18 June 2017 Available online 28 March 2018 Keywords: Stellate ganglion block (SGB) Neuropathic pain Pulsed RF

a b s t r a c t Objective: To assess the efficacy and safety of fluoroscopic–guided versus ultrasound (US)-guided techniques for pulsed radiofrequency (RF) therapy of stellate ganglion for refractory neuropathic pain syndromes. Methods: 40 patients with severe chronic neuropathic pain syndromes, Visual Analogue Scale (VAS) score > 7, with poor response to medical treatment were randomly integrated into 2 groups: Group (F): (20 patients) in whom pulsed R.F. therapy is done under fluoroscopy, group (U): (20 patients) in whom pulsed R.F. therapy is done under US guidance. Results: The current study revealed that there is significant reduction of VAS, and of the medical treatment consumption after the block as compared with pre block values, there is no statistically significant difference between the guidance techniques of RF treatment in pain relief. However, the procedure time was significantly lower in U group. Conclusion: Pulsed R.F. blockade of the stellate ganglion in patients with refractory neuropathic pain syndromes can be done safely and efficiently under the guidance of either ultrasound or fluoroscopy. Both radiological techniques provide similar satisfactory guidance without significant complications. Ó 2018 The Egyptian Society of Radiology and Nuclear Medicine. Production and hosting by Elsevier. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/ 4.0/).

1. Introduction The stellate (cervico-thoracic) ganglion is the result of fusion of the inferior cervical sympathetic ganglion with the first thoracic one and this fusion occurs in 80% of population. It is star shaped and measures 2.5 cm long, 1 cm wide and 0.5 cm thick and lies in front of C7 transverse process and the head of first rib [1]. Stellate ganglion blockade is utilized as diagnostic, prognostic or therapeutic intervention for sympathetic-mediated (maintained) pain, neuropathic pain syndromes and a lot of clinical implications [2]. Stellate ganglion blockade has been proven to be of value in vascular insufficiency of the upper limb such as Raynaud’s disease, vasospasm, embolic vascular disease, Paget’s disease, scleroderma,

Peer review under responsibility of The Egyptian Society of Radiology and Nuclear Medicine. ⇑ Corresponding author. E-mail addresses: [email protected] (M.H. Shaaban), [email protected] (R.M. Reyad), [email protected] (H.Z. Ghobrial), [email protected] (R.H. Hashem).

palmar hyperhydrosis, and in many pain syndromes like phantom limb pain, complex regional pain syndrome (CRPS), post-herpetic neuralgia, diabetic neuropathy, vascular headache, atypical facial pain and tic douloureux [3,4]. Other indications of left-stellate block are prinzemetal angina, prolonged Q-T syndrome and massive pulmonary embolism (bilateral block) [4]. On the other hand, stellate ganglion blockade is not a risk-free technique due to close proximity of a variety of vital structures. The vertebral artery originates from subclavian artery and lies anterior to the stellate ganglion at C7 level, then passing over the ganglion to enter the vertebral foramen. It lies posterior to C6anterior tubercle. The ganglion is bounded medially by longus colli muscles, laterally by scalene muscles, anteriorly by subclavian artery, posteriorly by prevertebral fascia and transverse process, inferiorly by the pleura. Other important nervous structures related to the ganglion include the phrenic nerve (lateral), the recurrent laryngeal nerve (antero-medial) and the C8-T1 anterior divisions (posterior) [3,5]. Different modalities have been tried to block the stellate ganglion including local anesthetics, steroids, neurolytic agents

https://doi.org/10.1016/j.ejrnm.2017.06.008 0378-603X/Ó 2018 The Egyptian Society of Radiology and Nuclear Medicine. Production and hosting by Elsevier. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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(phenol in saline 3%) [6] and radiofrequency therapy (pulsed or thermal) [7]. Radiofrequency neurolysis is an extension of continuous regional sympathetic blockade [8] or chemical neurolysis with longterm efficacy and more safety together with less morbidity than open surgical techniques [9]. Multiple imaging guidance are in use to perform stellate block whether ultrasound (which provide clear visualization of vascular and soft tissues structures) [10], MRI, CT and plain fluoroscopy [2]. Fluoroscopic approaches to block the stellate are either anterior (C6–C7), oblique or posterior [1,3,6]. In this prospective controlled study, we tried to compare the efficacy and safety of fluoroscopic–guided versus U/S-guided techniques for pulsed radiofrequency therapy of stellate ganglion aiming that the resulting sympathectomy may help to alleviate refractory neuropathic pain syndromes. 2. Patients and methods After approval of local ethical committee and obtaining informed consent, 40 patients were randomly selected from the pain clinic of National Cancer Institute (NCI) Cairo University between August 2011 and February 2014. All patients had chronic neuropathic pain syndromes in the upper limb with severe pain (VAS score > 7) refractory to strong opioids (morphine sulfate tablets) and adjuvant therapy (pre-gabalin Capsules) or experiencing intolerable side effects. Patients with local and systemic sepsis, coagulopathy, local anatomical distortion (post-operative or postradiotherapy) making the procedure difficult or hazardous are excluded from the study. Also patients with history of contralateral chest disease or pneumonectomy, glaucoma, recent M.I. or severe bradyarrythmias or heart block and allergy to the used medications, were excluded from the study. 3. Patients were randomly integrated into 2 equal groups Group (F): (20 patients) in whom pulsed R.F. therapy is done under fluoroscopy. Group (U): (20 patients) in whom pulsed R.F. therapy is done under US guidance.

shadow (on lateral view), not taking vascular, epidural, intrathecal or muscular pattern (Fig. 1B). Then the suitable R.F. electrode was inserted and connected to Bailys generator. Impedance should be 250–350 and no paresthesia is felt with sensory stimulation (50 Hz to 1.0–1.5 V) particularly in the upper limb and motor stimulation should be negative (while the patient saying E-E) at 2 Hz and 3 V. 3 ml lidocaine 2% plus 1 ml diprofos (5mg betamethosone) was injected. After 30–60 s, we used pulsed RF protocol with time = 8 min, temperature = 42 °C and pulse width = 10 m s. 5. Ultrasound technique [10] The patient was prepared as before. High-resolution ultrasound imaging for identification of small nerves and the interface between bone and soft tissues, with Doppler for the nearby vessels (vertebral, superior and inferior thyroid vessels). Siemens Acuson  700 U/S machine with high frequency linear transducer was used for superficial targets. Anterolateral margin of C6 body with the transverse process was identified. The target point is identified by the 4–12 MHz linear-array probe and check the R.F. needle orientation (looking at thyroid anteriorly and esophagus posteriorly) we used out of plane technique. Then the needle was withdrawn and reinserted obliquely so that the needle tip lie anterior to longus coli muscle (anterior to C6 transverse process). After negative aspiration, 1 ml of normal saline was injected which should spread adequately up and down without vascular uptake (Fig. 2). Then pulsed R.F. was done as previously after sensory and motor stimulation then 3 ml of lidocaine 2% plus 1 ml diprofos was injected. After stellate ganglion block was performed, to confirm stellate ganglion block, touch temperature thermometer was used to compare between both sides, then the site of procedure was draped with sterile pad and ice pack is applied to reduce hematoma. The patient is monitored for 2 h vitally and all patients of both groups are screened 2 h after the procedure by plain radiography to exclude pneumothorax and by neck ultrasound for hidden hematoma possibility .The patients were instructed before discharge to call the physician urgently if severe chest pain, dyspnea, CVS collapse, dysphonia, severe pain and motor deficit develop. 6. Patient evaluation

ASA-standard monitors (ECG, non-invasive blood pressure and pulse oxymitery) were connected to all patients. I.V. line (G-20) and O2 (3 L/min) through nasal pronge were used. Midazolam 0.02 mg/kg and fentanyl 1 Ug/kg (conscious sedation) were used. The patient was asked to lie supine over radiolucent table with the neck extended and a small pillow under shoulders. The field was sterilized with 10% betadine (povidone-iodine) and draped. The patient was foretold to communicate by moving the contralateral hand and not to speak or swallow during needling. 4. Fluoroscopic-technique (anterior approach) Visualization of C6-C7 level was attained through PA after good alignment was obtained by caudocephalic orientation (C7 level is identified by the nearby T1-transverse process ballooning). Then, the C-arm was turned 5-10o ipsilateral to open the vertebrotransverse junction at C7. At this point of entry, 1% lidocaine was infliterated S.C. using 22 G needle. Then R.F. needle (curved, sharp, 22 G, 50 or 100 ml length with 10 mm active tip) was advanced using tunnel technique until bony contact was made at the anterolateral side of C7 vertebra (Fig. 1A). After negative aspiration (For blood, CSF or air), 3 ml of contrast medium (iohexol, omnipaque) was injected. It should outline the retropharyngeal space, longitudinal, huking the lateral vertebral margin, within the vertebral

The patients were assessed for pain relief (VAS score), opioid and pregabalin consumption prior to block and at 1 day 1, 4, 12 weeks afterwards. Both morphine and pregabalin were stopped and the patient had free access to immediate release morphine (Sevradol 10 mg) and reassessed after 2 and 7 days to estimate the new escalating dose. Complications including Horner’s, nerve palsies (recurrent laryngeal, phrenic and lower brachial plexus), vascular (vertebral and carotid arteries) and pleural injuries, epidural or subarachnoid injection, esophageal puncture, hematoma and osteomyelitis all were reported. 7. Statistical analysis Descriptive tables and statistical analysis were made by software SPSS (Statistical package for social science) version11.0 statistical program. Parametric data were represented as mean and standard deviation; meanwhile, nonparametric data were represented as median and interquartile range. Within group comparison for the difference of VAS score, morphine consumption, and pregabalin consumption was done using paired t test. Meanwhile, comparison between the groups at specific time intervals was made by Mann-Whitney U test. A significant difference was accepted at P < .05.

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(A) RF needle at C7 level both at AP (end-on) and lateral view Fig. 1A. RF needle at C7 level both at AP (end-on) and lateral view.

(B) Both A-P and lateral view after injection of contrast medium showing free up and down para vertebral spread Fig. 1B. Both A-P and lateral view after injection of contrast medium showing free up and down para vertebral spread.

ICA TV

LCM

A

B

Fig. 2. Sonar guidance showing needle pass (arrowed) A. spread after injectate (arrowed) B. ICA = internal carotid artery TV = transverse process LCM = Longus colli muscle.

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M.H. Shaaban et al. / The Egyptian Journal of Radiology and Nuclear Medicine 49 (2018) 71–75 Table 2 Duration of the procedure (min).

8. Results The study included 40 cases with sympathetic mediated pain in the upper limb. The demographic characteristics of the two study groups are presented in Table 1. The two groups did not differ statistically in age, weight, distribution of sex; however the duration of procedure is significantly longer in F group with P value .03 (see Table 2). VAS values didn’t differ significantly among the two groups allover the study period, but both groups showed significant reduction of pain scores after block at all assessment time points, compared to pre-block baseline values (Table 3). Regarding morphine consumption, there was a significant reduction in mean daily consumption at 1 week, 1 month and 3 month compared to pre-block consumption in both groups, however, no significant difference in morphine consumption was noticed between the two studied groups at all time of measurements (Table 4). Regarding pregabalin consumption, there was a significant reduction in mean daily consumption at 1 week, 1 month and 3 month compared to pre-block consumption in both groups, however, no significant difference in pregabalin consumption was noticed between the two studied groups at all time of measurements (Table 5). The recorded side effects were minimal, reversible and disappeared in few hours to few days period (Table 6). No serious complications were recorded as pneumothorax, epidural or intrathecal injection or permanent Horner syndrome. No significant difference was detected between groups as regard side effects or complications. No technical difficulties or complications were faced during procedure performance.

9. Discussion The anatomical location of stellate ganglion and its close proximity to vital neurovascular and other structures making the stellate blockade vulnerable to a lot of serious hazards, hence, an imaging guidance is a routine nowadays. Traditionally interventional pain procedures including stellate ganglion blockade are done under fluoroscopy. However this standard guidance cannot visualize the soft tissues and exposes both the patient and workers to risk of irradiation. CT-guidance on the other hand, is speculated to major blocks such as coeliac plexus block and percutaneous cervical cordotomy as it exposes the patient and operators to risk of radiation and it is not easily available [11]. MRI-guided work is time consuming, cost-ineffective and impractical [10]. More recently, the use of ultrasound guidance has allowed stellate ganglion block to be performed without vascular or nerve injury [12,13]. Ultrasound can precisely locate the blood vessels (carotid, vertebral and thyroid vessels), nerves (cervical nerve roots, phrenic, recurrent laryngeal and divisions of the brachial

Table 1 Demographic characteristics. Variable

Group F (n = 20)

Group U (n = 20)

Age (year) Male/female ratio Body weight (kg)

44.3 ± 8.3 6/14 67.6 ± 7.4

46.1 ± 11.4 7/13 72.5 ± 7.2

Type of neuropathic pain Post mastectomy CRPS Phantom pain

12 6 2

11 8 1

Data are represented as mean ± standard deviation, ratio or number. p < .05 in comparison between both groups.

*

Duration of the procedure (min)

15.5 ± 3.2

11.7 ± 2.4*

Data are represented as mean ± SD. * p < .05 in comparison between both groups.

plexus) together with other important soft tissues (longus colli muscle, esophagus, trachea, mediastinum and thyroid gland) [10]. In the current study, forty patients, were treated using PRF of the stellate ganglion for control of chronic neuropathic pain syndrome, there is significant reduction of VAS, morphine consumption and pregabalin consumption after the block as compared with pre block values. These findings agreed with Kim et al. studying Twelve CRPS patients who underwent PRF on the cervical sympathetic chain . The pain intensity decreased significantly at 1 week after the procedure. In his study, overall, 91.7% of patients experienced at least moderate improvement [12]. Imani et al., studying 14 patients with CRPS underwent stellate ganglion block divided into 2 equal groups according whether fluoroscopic or ultrasound guided procedure found a meaningful statistical difference among patients of any group in terms of the pain intensity (before the block until six month after the block) [14]. However, in the present analysis, there is no significant difference between the fluoroscopic guided group and the ultrasound guided group regarding the pain scores and the morphine consumption dose before and after the procedure and all over the study period, agreeing with Imani et al., which stated no meaningful statistical difference between the patients of ultrasound and fluoroscopic guidance groups, in terms of the pain intensity (from one week to six months after block) [14]. In the current study, the procedure time was significantly lower in the ultrasound guided block compared with the fluoroscopic guided block. The results of this study showed shorter procedure time in ultrasound guidance may be due to different views taken by fluoroscopy with and without dye. Also the incidence of hematoma formation and hoarseness of voice was lower in the ultrasound guided block group. Agreeing with Lee et al. who stated that the ultrasound technique improves the safety of the procedure through the direct visualization of the related soft tissue structures that are not visualized with fluoroscopy [15]. The source of such Hematoma could be due to injury of the thyroid tissue or thyroid vessels [16,17]. Kapral et al. compared sonar guided stellate block with blind technique and found that good block with sonar guidance with 100% success rate and lower incidence of hematoma with 3 patients in blind group and none in US group [16]. During Fluoroscopic technique, the patient neck is hyperextended by small pillow under the shoulder to stretch the esophagus in the midline behind the trachea away from the needle path. However, the risk of esophageal penetration and consequently mediastinal infection and emphysema is still a problem [10]. US easily identify the esophagus and thus will be of great value in cases of esophageal diverticulum [10]. PRF on the cervical sympathetic chain therefore appears to be a valid option for the management of CRPS of the upper extremities, and the incorporation of ultrasound can increase the ease and safety of this procedure [12]. Limitations of the current study is the inability to assess long term effects of the treatment, as the follow up period was limited to 3 month post procedure. To sum up, the present results support the opinion that sympathetic blockade in stellate ganglion using pulsed radiofrequency is of reasonable efficacy in treating chronic neuropathic pain whether

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M.H. Shaaban et al. / The Egyptian Journal of Radiology and Nuclear Medicine 49 (2018) 71–75 Table 3 The median VAS score values in the two studied groups. Group/time Group F (n = 20) Group U (n = 20)

Before the block

24 h after

1 week after

*

8.5 (7, 9) 8 (8, 9)

*

1 (0, 2) 1 (0, 3)*

2 (1, 4) 2 (1, 3)*

1 month after *

3 (2, 4) 4 (1, 5)*

3 month after 3 (2, 5)* 4 (2, 5)*

Data are represented as median (IQ). * P < .05 in comparison to before block value in the same group.

Table 4 Mean daily morphine consumption, in mgs, in the two studied groups. Group/time

Before the block

1 week after

1 month after

3 month after

Group F (n = 20) Group U (n = 20)

75 ± 12.4 80 ± 10.6

20 ± 4.3 * 25 ± 5.4*

30 ± 6.4* 30 ± 4.4*

35 ± 7.8* 35 ± 6.7*

Data are represented as mean ± SD. * p < .05 in comparison to before block value in the same group.

Table 5 Mean daily pregabalin consumption in the two studied groups. Group/time

Before block

1 week after

1 month after

3 month after

Group F (n = 20) (mg) Group U (n = 20) (mg)

375 ± 30.5 405 ± 35.7

120 ± 15.7* 135 ± 20.8*

145 ± 30.5* 175 ± 45.6*

165 ± 35.8* 190 ± 40.6*

Data are represented as mean ± SD. * p < .05 in comparison to before block value in the same group.

Table 6 Side effects and complications. [4] Side effect/group

Group F (n = 20)

Group U (n = 20)

Pain at puncture site Temporary horner syndrome Hematoma Hoarseness of voice

8 (40%) 17 (85%) 2 (10%) 1 (5%)

11 (55%) 16 (80%) 0 0

Data are represented as number (percentage).

[5] [6] [7]

[8] [9]

fluoroscopic or ultrasound guided, yet ultrasound takes considerably less time with less complications.

[10] [11]

Conflict of interest [12]

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