Liposomal Bupivacaine in Implant Based Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Liposomal Bupivacaine in Implant Based Breast Reconstruction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02659501
• Other study ID #: 5150012
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Liposomal bupivacaine
Liposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action.
• Bupivacaine with epinephrine
Bupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia.
• Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
• Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
• Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.

Locations

Country	Name	City	State
United States	Loma Linda University Health System	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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):1010-8. doi: 10.1097/PRS.0b013e3181858c09. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.	Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.	Average Pain Scores 24 hours Post-Operatively
Primary	The Effect of Liposomal Bupivacaine on Antiemetic Consumption	The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.	24 hours
Primary	The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption	Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.	24 hours
Primary	The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption	Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.	24 hours
Primary	The Effect of Liposomal Bupivacaine on Length of Hospital Stay	Length of hospital stay will be determined for patients in each group, in total hours.	24-60 hours