- Email: [email protected]
A randomized controlled trial of postoperative pain control after subpectoral breast augmentation using intercostal nerve block versus bupivacaine pectoralis major infiltration: A pilot study
+
MODEL
Journal of Plastic, Reconstructive & Aesthetic Surgery (2015) xx, e1ee2
CORRESPONDENCE AND COMMUNICATION A randomized controlled trial of postoperative pain control after subpectoral breast augmentation using intercostal nerve block versus bupivacaine pectoralis major infiltration: A pilot study Dear Sir, Cosmetic breast augmentation though continuously gaining popularity, is certainly not pain free. The subpectoral approach further increases postoperative pain, due to muscle trauma induced by surgical dissection. In an effort to improve overall patient satisfaction, numerous alternatives to narcotics have been studied.1 To date, no standard of care exists and management is based on surgeon and anesthesiologists preferences. The purpose of our study is to prospectively evaluate the role of Intercostal Nerve Block (ICNB) and Pectoralis Major Muscle Infiltration (PMMI) in pain management following subpectoral breast augmentation. After Institutional Review Board approval at Hotel-Dieu de France Hospital, women aged 18 years or older, of ASA1, undergoing primary bilateral subpectoral breast augmentation from July 2012 through July 2013, were preoperatively consented and enrolled. Exclusion criteria consisted of a known allergy to local anesthetic, subglandular breast augmentation, concomitant surgeries, pregnancy, history of chronic pain or substance abuse. The same primary surgeon (M.W.N.) performed all cases. The technique consisted of a periareolar incision and transglandular approach with partial subpectoral augmentation using round textured implants. Patients received general anesthesia and were randomly allocated to two cohorts. Both cohorts received PMMI using 20 mL of 0.25% bupivacaine with epinephrine (5 mg/mL) on one breast. The contralateral breast was treated with ICNB in cohort 1 or with placebo infiltration of
the pectoralis major muscle using 20 mL of normal saline in cohort 2. Treatment laterality was randomly determined. PMMI was performed by the primary surgeon intraoperatively by infiltrating the inferior cut end of the muscle prior to implant placement. ICNB was executed by the anesthesiologist prior to skin incision using a 10 cm 22gauge needle advanced into the intercostal space at the midaxillary line. Each T2eT7 segment was blocked with 3 mL of 0.25% bupivacaine with epinephrine, and the pectoralis minor muscle was infiltrated with 2 mL. The total amount of bupivacaine with epinephrine injected did not exceed the recommended safe dose of 2.5 mg/kg. Postoperatively, a standardized intravenous analgesic protocol consisting of 1 g of acetaminophen every 6 h, 50 mg of ketoprofen every 6 h and 1 mg/kg of tramadol every 8 h was used. Patients reported the pain felt on each breast at 0, 1, 3, 8 and 24 h at rest and after movement using the 10-point Visual Analog Scale. Patient satisfaction was noted at the 2-week postoperative visit. The primary outcome of the study was the difference in pain scores between the breast treated with PMMI and the contralateral breast over time and was analyzed using a mixed effect linear regression model (Stata 12, College Station, TX, USA). Twenty-eight consecutive women were enrolled in the study: 13 and 15 patients in cohorts 1 and 2 respectively. Patients in each cohort were randomly assigned to right or left PMMI. None were lost to follow-up. Table 1 depicts demographic and surgical results in both cohorts. Whenever intended, PMMI and ICNB were easily performed and no complications were described. All patients were satisfied with the final esthetic results. Postoperative pain gradually decreased with time in all patients. There was no difference in pain on admission to the recovery room at rest in cohorts 1 (p Z 0.98) and 2 (p Z 0.23) or after movement in cohorts 1 (p Z 0.79) and 2 (p Z 0.15). Using the mixed regression model, no difference in pain scores was found over time at rest or on movement when comparing PMMI to ICNB or PMMI to Placebo (Table 2). Our study failed to demonstrate any statistically significant difference in pain scores when comparing PMMI to placebo or PMMI to ICNB. Though PMMI and ICNB seem to offer attractive alternatives to traditional methods of analgesia, there are conflicting data in the literature
http://dx.doi.org/10.1016/j.bjps.2014.12.035 1748-6815/ª 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Nasr MW, et al., A randomized controlled trial of postoperative pain control after subpectoral breast augmentation using intercostal nerve block versus bupivacaine pectoralis major infiltration: A pilot study, Journal of Plastic, Reconstructive & Aesthetic Surgery (2015), http://dx.doi.org/10.1016/j.bjps.2014.12.035
+
MODEL
e2 Table 1
Correspondence and communication
20.84 (2.17) 20.10 (1.715) 2 [0e4] 1 [0e3]
20.44 (1.92)
randomized design using patients as their own controls. By comparing analgesic outcomes in the same patient, we were able to control for the subjectivity of pain assessments. In conclusion, ICNB and PMMI do not offer analgesic benefits following breast augmentation. Larger randomized trials are needed to confirm the results of our pilot study.
1 [0e4]
Ethical approval
301.92 (39.78)
293.93 (36.83)
The study was approved by the Institutional Review Board at Hotel Dieu de France Hospital.
Demographic and surgical characteristics.
Variable
Cohort 1
Cohort 2
Combined cohorts
Age, years, mean (SD) BMI, kg/m2, mean (SD) Parity, median [range] Implant volume, mL, mean (SD)
30.31 (4.87) 30.13 (6.60) 30.21 (5.70)
287 (32.17)
BMI: body mass index.
Funding Table 2 Mean change in pain scores over time using the mixed regression model.
PMMI versus ICNB at rest PMMI versus ICNB on movement PMMI versus Placebo at rest PMMI versus Placebo on movement
P value*
95% Confidence Interval
0.91 0.92
[ 0.05, 0.04] [ 0.06, 0.07]
0.78 0.90
[ 0.04, 0.03] [ 0.04, 0.03]
PMMI: pectoralis major muscle infiltration; ICNB: intercostal nerve block. *A P value <0.05 was considered statistically significant.
regarding their efficacy. ICNB failed to reduce postoperative pain following subpectoral breast augmentation in some comparative trials,2 whereas Sangdal et al. demonstrated efficient analgesia lasting for 48 h.3 On the other hand, PMMI with bupivacaine was shown to decrease pain perception and postoperative analgesic use in a study limited by its retrospective nature.4 The systematic use of a postoperative multimodal protocol could have decreased postoperative pain efficiently and made it more difficult for patients to depict variations in the intensity of their pain. On the other hand, the failed effect of ICNB to significantly decrease postoperative pain may be explained by the fact that pain following subpectoral augmentation is predominantly channeled by the thoracoacromial trunk. A study by Blanco demonstrated that the combination of ICNB to pectoralis major muscle nerve block is required for complete breast analgesia.5 Our study differs from the literature in its prospective,
None.
Conflict of interest statement None.
References 1. Stanley SS, Hoppe IC, Ciminello FS. Pain control following breast augmentation: a qualitative systematic review. Aesthet Surg J 2012;32:964e72. 2. Hidalgo D, Pusic A. The role of methocarbamol and intercostal nerve blocks for pain management in breast augmentation. Aesthet Surg J 2005;25:571e5. 3. Sangdal Lee SK. The analgesic effects of intercostal nerve block in patients undergoing augmentation mammoplasty. J Breast Cancer 2006;9:349e53. 4. Jabs D, Richards B, Richards F. Quantitative effects of tumescent infiltration and bupivacaine injection in decreasing postoperative pain in submuscular breast augmentation. Aesthet Surg J 2008;28:528e33. 5. Blanco R. The “pecs block”: a novel technique for providing analgesia after breast surgery. Anaesthesia 2011;66:847e8.
Marwan W. Nasr Samer B. Habre Hicham Jabbour Andre Baradhi Ziad El Asmar Hoˆtel Dieu de France Hospital, Beirut, Lebanon E-mail address: [email protected] 22 June 2014
Please cite this article in press as: Nasr MW, et al., A randomized controlled trial of postoperative pain control after subpectoral breast augmentation using intercostal nerve block versus bupivacaine pectoralis major infiltration: A pilot study, Journal of Plastic, Reconstructive & Aesthetic Surgery (2015), http://dx.doi.org/10.1016/j.bjps.2014.12.035
MODEL
Journal of Plastic, Reconstructive & Aesthetic Surgery (2015) xx, e1ee2
CORRESPONDENCE AND COMMUNICATION A randomized controlled trial of postoperative pain control after subpectoral breast augmentation using intercostal nerve block versus bupivacaine pectoralis major infiltration: A pilot study Dear Sir, Cosmetic breast augmentation though continuously gaining popularity, is certainly not pain free. The subpectoral approach further increases postoperative pain, due to muscle trauma induced by surgical dissection. In an effort to improve overall patient satisfaction, numerous alternatives to narcotics have been studied.1 To date, no standard of care exists and management is based on surgeon and anesthesiologists preferences. The purpose of our study is to prospectively evaluate the role of Intercostal Nerve Block (ICNB) and Pectoralis Major Muscle Infiltration (PMMI) in pain management following subpectoral breast augmentation. After Institutional Review Board approval at Hotel-Dieu de France Hospital, women aged 18 years or older, of ASA1, undergoing primary bilateral subpectoral breast augmentation from July 2012 through July 2013, were preoperatively consented and enrolled. Exclusion criteria consisted of a known allergy to local anesthetic, subglandular breast augmentation, concomitant surgeries, pregnancy, history of chronic pain or substance abuse. The same primary surgeon (M.W.N.) performed all cases. The technique consisted of a periareolar incision and transglandular approach with partial subpectoral augmentation using round textured implants. Patients received general anesthesia and were randomly allocated to two cohorts. Both cohorts received PMMI using 20 mL of 0.25% bupivacaine with epinephrine (5 mg/mL) on one breast. The contralateral breast was treated with ICNB in cohort 1 or with placebo infiltration of
the pectoralis major muscle using 20 mL of normal saline in cohort 2. Treatment laterality was randomly determined. PMMI was performed by the primary surgeon intraoperatively by infiltrating the inferior cut end of the muscle prior to implant placement. ICNB was executed by the anesthesiologist prior to skin incision using a 10 cm 22gauge needle advanced into the intercostal space at the midaxillary line. Each T2eT7 segment was blocked with 3 mL of 0.25% bupivacaine with epinephrine, and the pectoralis minor muscle was infiltrated with 2 mL. The total amount of bupivacaine with epinephrine injected did not exceed the recommended safe dose of 2.5 mg/kg. Postoperatively, a standardized intravenous analgesic protocol consisting of 1 g of acetaminophen every 6 h, 50 mg of ketoprofen every 6 h and 1 mg/kg of tramadol every 8 h was used. Patients reported the pain felt on each breast at 0, 1, 3, 8 and 24 h at rest and after movement using the 10-point Visual Analog Scale. Patient satisfaction was noted at the 2-week postoperative visit. The primary outcome of the study was the difference in pain scores between the breast treated with PMMI and the contralateral breast over time and was analyzed using a mixed effect linear regression model (Stata 12, College Station, TX, USA). Twenty-eight consecutive women were enrolled in the study: 13 and 15 patients in cohorts 1 and 2 respectively. Patients in each cohort were randomly assigned to right or left PMMI. None were lost to follow-up. Table 1 depicts demographic and surgical results in both cohorts. Whenever intended, PMMI and ICNB were easily performed and no complications were described. All patients were satisfied with the final esthetic results. Postoperative pain gradually decreased with time in all patients. There was no difference in pain on admission to the recovery room at rest in cohorts 1 (p Z 0.98) and 2 (p Z 0.23) or after movement in cohorts 1 (p Z 0.79) and 2 (p Z 0.15). Using the mixed regression model, no difference in pain scores was found over time at rest or on movement when comparing PMMI to ICNB or PMMI to Placebo (Table 2). Our study failed to demonstrate any statistically significant difference in pain scores when comparing PMMI to placebo or PMMI to ICNB. Though PMMI and ICNB seem to offer attractive alternatives to traditional methods of analgesia, there are conflicting data in the literature
http://dx.doi.org/10.1016/j.bjps.2014.12.035 1748-6815/ª 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Nasr MW, et al., A randomized controlled trial of postoperative pain control after subpectoral breast augmentation using intercostal nerve block versus bupivacaine pectoralis major infiltration: A pilot study, Journal of Plastic, Reconstructive & Aesthetic Surgery (2015), http://dx.doi.org/10.1016/j.bjps.2014.12.035
+
MODEL
e2 Table 1
Correspondence and communication
20.84 (2.17) 20.10 (1.715) 2 [0e4] 1 [0e3]
20.44 (1.92)
randomized design using patients as their own controls. By comparing analgesic outcomes in the same patient, we were able to control for the subjectivity of pain assessments. In conclusion, ICNB and PMMI do not offer analgesic benefits following breast augmentation. Larger randomized trials are needed to confirm the results of our pilot study.
1 [0e4]
Ethical approval
301.92 (39.78)
293.93 (36.83)
The study was approved by the Institutional Review Board at Hotel Dieu de France Hospital.
Demographic and surgical characteristics.
Variable
Cohort 1
Cohort 2
Combined cohorts
Age, years, mean (SD) BMI, kg/m2, mean (SD) Parity, median [range] Implant volume, mL, mean (SD)
30.31 (4.87) 30.13 (6.60) 30.21 (5.70)
287 (32.17)
BMI: body mass index.
Funding Table 2 Mean change in pain scores over time using the mixed regression model.
PMMI versus ICNB at rest PMMI versus ICNB on movement PMMI versus Placebo at rest PMMI versus Placebo on movement
P value*
95% Confidence Interval
0.91 0.92
[ 0.05, 0.04] [ 0.06, 0.07]
0.78 0.90
[ 0.04, 0.03] [ 0.04, 0.03]
PMMI: pectoralis major muscle infiltration; ICNB: intercostal nerve block. *A P value <0.05 was considered statistically significant.
regarding their efficacy. ICNB failed to reduce postoperative pain following subpectoral breast augmentation in some comparative trials,2 whereas Sangdal et al. demonstrated efficient analgesia lasting for 48 h.3 On the other hand, PMMI with bupivacaine was shown to decrease pain perception and postoperative analgesic use in a study limited by its retrospective nature.4 The systematic use of a postoperative multimodal protocol could have decreased postoperative pain efficiently and made it more difficult for patients to depict variations in the intensity of their pain. On the other hand, the failed effect of ICNB to significantly decrease postoperative pain may be explained by the fact that pain following subpectoral augmentation is predominantly channeled by the thoracoacromial trunk. A study by Blanco demonstrated that the combination of ICNB to pectoralis major muscle nerve block is required for complete breast analgesia.5 Our study differs from the literature in its prospective,
None.
Conflict of interest statement None.
References 1. Stanley SS, Hoppe IC, Ciminello FS. Pain control following breast augmentation: a qualitative systematic review. Aesthet Surg J 2012;32:964e72. 2. Hidalgo D, Pusic A. The role of methocarbamol and intercostal nerve blocks for pain management in breast augmentation. Aesthet Surg J 2005;25:571e5. 3. Sangdal Lee SK. The analgesic effects of intercostal nerve block in patients undergoing augmentation mammoplasty. J Breast Cancer 2006;9:349e53. 4. Jabs D, Richards B, Richards F. Quantitative effects of tumescent infiltration and bupivacaine injection in decreasing postoperative pain in submuscular breast augmentation. Aesthet Surg J 2008;28:528e33. 5. Blanco R. The “pecs block”: a novel technique for providing analgesia after breast surgery. Anaesthesia 2011;66:847e8.
Marwan W. Nasr Samer B. Habre Hicham Jabbour Andre Baradhi Ziad El Asmar Hoˆtel Dieu de France Hospital, Beirut, Lebanon E-mail address: [email protected] 22 June 2014
Please cite this article in press as: Nasr MW, et al., A randomized controlled trial of postoperative pain control after subpectoral breast augmentation using intercostal nerve block versus bupivacaine pectoralis major infiltration: A pilot study, Journal of Plastic, Reconstructive & Aesthetic Surgery (2015), http://dx.doi.org/10.1016/j.bjps.2014.12.035