CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Ropivacaine 0.2% Injectable Solution +1 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04474366
NCT04474366Phase 4Completed

The Effect of Pectoral Blocks on Perioperative Pain in Simple Mastectomy and Breast Reduction in Gender Affirmation Surgery

University of California, San Francisco·interventional·Posted Jul 16, 2020·Updated Jul 3, 2023

In Brief

A Phase 4 clinical trial evaluating Ropivacaine 0.2% Injectable Solution and Saline (0.9%) for Gender Dysphoria and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Despite recent advancements with regional and local anesthesia, postoperative pain continues to be a major concern for patients undergoing breast surgery. Opioids, often in combination with NSAIDS and/or gabapentioids, have been the main pharmacologic pain control strategy in the postoperative period. The pectoral nerve block is a regional anesthetic technique, which is effective at providing postoperative anesthesia in breast surgeries. However, this has only been studied in oncologic-related breast operations. It is our aim to study the effects of pectoral regional nerve blocks in patients undergoing breast reduction for gender affirmation. The overall goal is to establish an effective pain control regimen utilizing regional anesthetic techniques in this patient population. The specific objective of this proposal is to evaluate the effectiveness of these blocks on perioperative and postoperative analgesia. The hypothesis is that participants undergoing gender-affirmation breast surgery who receive a pectoral nerve block will have less perioperative and postoperative pain as well as reduced opioid consumption compared to those receiving a placebo. Participants who are undergoing gender affirmation breast reduction surgery will be randomized to either receive a preoperative nerve block or to receive a placebo. Intraoperative and postoperative opioid requirements will be compared in addition to post-operative pain scores. Participants will be asked to fill out a pain diary during their first week postoperatively. They will also be asked to document if, and when, narcotic pain medication was required for pain control. The two groups will be compared to determine if there was any difference in pain scores as well as narcotic medication requirements.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 16, 2020
Enrollment StartJun 16, 2020
Primary CompletionFeb 28, 2022
Study CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.0 years ago

Interventions

Ropivacaine 0.2% Injectable Solutiondrug

Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block

Saline (0.9%)other

Saline injection as sham block in identical fashion as Pectoralis Nerve Block