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The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery

NCT04474366 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-03

Study results available
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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.

Conditions

  • Gender Dysphoria
  • Opioid Use
  • Pain, Postoperative

Interventions

DRUG

Ropivacaine 0.2% Injectable Solution

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

OTHER

Saline (0.9%)

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

Sponsors & Collaborators

Principal Investigators

  • Esther Kim, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2022-02-28
Completion
2022-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04474366 on ClinicalTrials.gov