Clinical trial NCT02659501: Liposomal Bupivacaine in Implant Based Breast Reconstruction
Official title: Liposomal Bupivacaine in Implant Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Postoperative Pain
Keywords: Breast reconstruction
Bupivacaine
Liposomal bupivacaine
Postoperative analgesia
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:

1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

Detailed description: Objectives:

1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

The objective of this project is to evaluate the role of liposomal bupivacaine in postoperative pain control following tissue expander and implant based breast reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This agent has been demonstrated to be safe, well tolerated, and effective in a number of different clinical applications. However, its role has yet to be evaluated in the context of breast reconstruction.

Thus, the authors propose the first, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following tissue expander and implant based breast reconstruction. Patients will be stratified into two study groups. Patients in the Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket. This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. This is the experimental intervention. Postoperatively, the investigators will assess pain levels, opioid consumption, opioid related adverse events, length of stay, and satisfaction.

The findings from this study will allow the authors to better elucidate the role of liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may allow the authors to identify the ideal pain regimen for these patients. This holds important implications, with the potential to reduce postoperative pain, opioid consumption, opioid related adverse events, length of stay, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Women undergoing immediate unilateral or bilateral tissue-expander breast reconstruction following skin-sparing or nipple-sparing mastectomy

Exclusion Criteria:

* Women who are unable to give informed consent to participate in this study
* Women with a documented history of hypersensitivity reactions to local-anesthetic agents
* Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
* Women who are currently pregnant
* Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander
* Women with impaired hepatic function

Primary outcomes:
measure: The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
timeFrame: Average Pain Scores 24 hours Post-Operatively
measure: The Effect of Liposomal Bupivacaine on Antiemetic Consumption
timeFrame: 24 hours
measure: The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
timeFrame: 24 hours
measure: The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
timeFrame: 24 hours
measure: The Effect of Liposomal Bupivacaine on Length of Hospital Stay
timeFrame: 24-60 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health System
state: California
Study officials:
affiliation: Loma Linda University
name: Subhas C. Gupta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University
name: Wendy W. Wong, MD
role: STUDY_DIRECTOR
References:
citation: Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
citation: Wheble GA, Tan EK, Turner M, Durrant CA, Heppell S. Surgeon-administered, intra-operative transversus abdominis plane block in autologous breast reconstruction: a UK hospital experience. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1665-70. doi: 10.1016/j.bjps.2013.07.017. Epub 2013 Jul 31.
citation: 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 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
citation: Richard BM, Ott LR, Haan D, Brubaker AN, Cole PI, Nelson KG, Ross PE, Rebelatto MC, Newton PE. The safety and tolerability evaluation of DepoFoam bupivacaine (bupivacaine extended-release liposome injection) administered by incision wound infiltration in rabbits and dogs. Expert Opin Investig Drugs. 2011 Oct;20(10):1327-41. doi: 10.1517/13543784.2011.611499. Epub 2011 Aug 26.
citation: Davidson EM, Barenholz Y, Cohen R, Haroutiunian S, Kagan L, Ginosar Y. High-dose bupivacaine remotely loaded into multivesicular liposomes demonstrates slow drug release without systemic toxic plasma concentrations after subcutaneous administration in humans. Anesth Analg. 2010 Apr 1;110(4):1018-23. doi: 10.1213/ANE.0b013e3181d26d2a.