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The Use Of Liposomal Bupivacaine For Pain Control

NCT03722927 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-10-27

Study results available
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Summary

The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.

Conditions

  • Pain, Breast

Interventions

DRUG

Bupivacaine

While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.

DRUG

Liposomal Bupivacaine

While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Christopher M Runyan, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-14
Primary Completion
2020-01-29
Completion
2020-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722927 on ClinicalTrials.gov