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NCT04474366 · ClinicalTrials.gov registry record · Phase 4
The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT04474366: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT04474366 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04474366, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.
Interventions
- DRUG Ropivacaine 0.2% Injectable Solution
- OTHER Saline (0.9%)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2022-04-30 |
| Phase | Phase 4 |
What the finished NCT04474366 record still lists
NCT04474366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Ropivacaine 0.2% Injectable Solution is the first listed.
NCT04474366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04474366 about?
NCT04474366 is a clinical study titled "The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery". 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 perio...
What is the current status of trial NCT04474366?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2020-06-16. Estimated completion is 2022-04-30.
What interventions are being tested in trial NCT04474366?
The interventions under investigation include: Ropivacaine 0.2% Injectable Solution (DRUG), Saline (0.9%) (OTHER).
Who is sponsoring clinical trial NCT04474366?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04474366's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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