Liposomal Bupivacaine in Implant Based Breast Reconstruction

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.

Conditions

• Breast Cancer
• Postoperative Pain

Interventions

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.

DRUG

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.

DRUG

Morphine sulfate

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

DRUG

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.

DRUG

Diazepam

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

Sponsors & Collaborators

• Loma Linda University

  lead OTHER

Principal Investigators

• Subhas C. Gupta, MD, PhD · Loma Linda University

• Wendy W. Wong, MD · Loma Linda University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2016-09-30

Completion

2017-07-31

Countries

• United States

Study Locations