Liposomal Bupivacaine in Implant Based Breast Reconstruction

NCT02659501 | Terminated Results

• 1 other identifier: 5150012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

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

Conditions

Breast Cancer; Postoperative Pain

Keywords

Breast reconstruction; Bupivacaine; Liposomal bupivacaine; Postoperative analgesia

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Bupivacaine with epinephrine injections

ACTIVE COMPARATOR

Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.

Drug: Bupivacaine with epinephrine; Drug: Morphine sulfate; Drug: Hydrocodone/acetaminophen; Drug: Diazepam

Liposomal bupivacaine

EXPERIMENTAL

Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.

Drug: Liposomal bupivacaine; Drug: Morphine sulfate; Drug: Hydrocodone/acetaminophen; Drug: Diazepam

Interventions

Liposomal bupivacaine DRUG

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.

Also known as: Exparel

Liposomal bupivacaine

Bupivacaine with epinephrine DRUG

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.

Also known as: Marcaine, Sensorcaine

Bupivacaine with epinephrine injections

Morphine sulfate DRUG

Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.

Also known as: Roxanol

Bupivacaine with epinephrine injections; Liposomal bupivacaine

Hydrocodone/acetaminophen DRUG

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.

Also known as: Norco

Bupivacaine with epinephrine injections; Liposomal bupivacaine

Diazepam DRUG

Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.

Also known as: Valium

Bupivacaine with epinephrine injections; Liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health System

Loma Linda, California, 92354, United States

Location

Related Publications (5)

• 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.

  PMID: 18827631 BACKGROUND

• 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.

  PMID: 23910912 BACKGROUND

• 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.

  PMID: 22900785 BACKGROUND

• 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.

  PMID: 21867476 BACKGROUND

• 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.

  PMID: 20357145 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Bupivacaine; Epinephrine; Morphine; oxycodone-acetaminophen; Diazepam

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Limitations and Caveats

Our trial was terminated after 12 months at 24 patients. Early termination lead to smaller numbers of subjects analyzed.

Results Point of Contact

• Title: Saba Motakef, Resident Physican
• Organization: Loma Linda University, Department of Plastic Surgery

smotakef@llu.edu

714-925-8932

Study Officials

• Subhas C. Gupta, MD, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

• Wendy W. Wong, MD

  Loma Linda University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: January 20, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: July 1, 2017
• Last Updated: January 12, 2021
• Results First Posted: August 21, 2019

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)