Intra-operative Use of Liposomal Bupivacaine and its Effect on Post-operative Pain in Breast Augmentation

Authors

  • Steven A. Clark Tulane University School of Medicine, New Orleans, LA 70112, USA
  • John T. Lindsey Tulane University School of Medicine, New Orleans, LA 70112, USA
  • Sara A. Gaines Tulane University School of Medicine, New Orleans, LA 70112, USA
  • Dietric L. Hennings Tulane University School of Medicine, New Orleans, LA 70112, USA
  • Karen D. Jordan Tulane University School of Medicine, New Orleans, LA 70112, USA

DOI:

https://doi.org/10.31907/2414-2093.2016.02.09

Keywords:

Post-operative pain, Pain score, Non-industry funded.

Abstract

Introduction: Liposomal bupivacaine (Exparel©, Pacira Pharmaceuticals, Inc., Parsippany, NJ) is a local anesthetic, approved by the FDA for introduction into surgical sites for post-operative analgesia in October of 2011. Pharmaceutical advertisements claim that Exparel© relieves pain up to 72 hours, and that patients may require less pain medication during their recovery. Currently there is limited data with few non-industry funded, controlled studies concerning its efficacy.

Methods: A single center, prospective open-label study was conducted over a year period comparing bupivacaine with epinephrine to liposomal bupivacaine, in regards to patient post-operative pain scores and narcotic usage on patients undergoing breast augmentation. All studied patients had breast augmentation with identical surgical technique. Studied patients had sub-muscularly placed saline implants performed by a single surgeon at one surgical facility.

Results: Thirty-two patients of 40 successfully participated in the study (11 in the control group and 21 in the experimental group). Patients who received liposomal bupivacaine reported lower pain scores which was statistically significant at p=0.02, however patients who received liposomal bupivacaine required more narcotics at 72 hours than patients in the control group. Statistical analysis showed a trend that patients who received liposomal bupivacaine used less hydrocodone post-operatively (p=0.05).

Conclusions: Patients who received liposomal bupivacaine reported improved pain scores compared to bupivacaine with epinephrine. The improved pain score was minimal, and did not translate into a significantly lower usage of narcotics post-operatively. Our data suggests that that liposomal bupivacaine only provides improved pain relief for 48 hours and not the advertised 72 hours.

References

Housman TS, Hancox JG, Mir MR, Camacho F, Fleischer AB, Feldman SR, et al. What specialties perform the most common outpatient cosmetic procedures in the United States? Dermatol Surg. 2008; 34: 1–7 discussion 8.

Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be under- managed. Anesth Analg. 2003; 97(2): 534-540. https://doi.org/10.1213/01.ANE.0000068822.10113.9E

Hospital Care Quality Information from the Consumer Perspective. http://www.hcahpsonline.org (Accessed August 22, 2012).

Zhao SZ, Chung F, Hanna DB, Raymundo AL, Cheung RY, Chen C. Dose-response relationship between opioid use and adverse effects after ambulatory surgery. J Pain Symptom Manage. 2004; 28(1): 35-46. https://doi.org/10.1016/j.jpainsymman.2003.11.001

Apseloff G, Onel E, Patou G. Time to onset of analgesia following local infiltration of liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort, crossover study. Int J Clin Pharmacol Ther. 2013; 51: 367- 373. https://doi.org/10.5414/CP201775

Pacira Parmaceuticals. Managing your pain. Parsippany NJ, July 2012.

Onel E. A phase 3 randomized, placebo-controlled trial of Exparel, an extended release bupivacaine local analgesic in bunionectomy. Orthopaedic Research Society 57th Annual Meeting. Long Beach CA. 2011.

Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011; 54(12): 1552-1559. https://doi.org/10.1097/DCR.0b013e318232d4c1

Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012; 19(5): 530- 536. https://doi.org/10.1016/j.knee.2011.12.004

Cohen S. Extended pain relief trial utilizing infiltration of Exparel®, a long-acting multivesicular liposome formulation of bupivacaine: a phase IV health economic trial in adult patients undergoing open colectomy. J Pain Res. 2012; 5: 567-72. https://doi.org/10.2147/JPR.S38621

Morales R Jr, Mentz H III, Newall G, Patronella C, Masters O. Use of abdominal field block injections with liposomal bupivicaine to control postoperative pain after abdominoplasty. Aesthet Surg J. 2013; 33: 1148-1153. https://doi.org/10.1177/1090820X13510720

Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012; 32: 69-76. https://doi.org/10.1177/1090820X11430831

Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012; 28: 1609-1615. https://doi.org/10.1185/03007995.2012.721760

United States. Food and Drug Administration. Exparel warning letter: NDA# 22496 / MA# 68. September 22, 2014.

Downloads

Published

2016-12-16

Issue

Section

Articles