CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3 enrolled
Drug / intervention
Bupivacaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03722927
NCT03722927Phase 4Completed

The Use of Liposomal Bupivacaine for Pain Control Following Mastectomy and Breast Reconstruction

Wake Forest University Health Sciences·interventional·Posted Oct 29, 2018·Updated Oct 27, 2022

In Brief

A Phase 4 clinical trial evaluating Bupivacaine and Liposomal Bupivacaine for Pain, Breast. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Breast
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 29, 2018
Enrollment StartJun 14, 2018
Primary CompletionJan 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.7 years ago

Interventions

Bupivacainedrug

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.

Liposomal Bupivacainedrug

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.