Last reviewed · How we verify
The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery
Phase 4 trial testing Ropivacaine 0.2% Injectable Solution in Gender Dysphoria in 50 participants. Completed in 30 April 2022.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 50 |
| Start date | 16 June 2020 |
| Primary completion | 28 February 2022 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across United States |
University of California, San Francisco
Adults 18 to 65, any sex, with Gender Dysphoria or Opioid Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Saline | 3.0 | ± 1.8 |
| Ropivacaine | 3.6 | ± 1.6 |
Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.
| Group | Value | 95% CI |
|---|---|---|
| Saline | 11.1 | ± 3.5 |
| Ropivacaine | 9.8 | ± 4.5 |
Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.
| Group | Value | 95% CI |
|---|---|---|
| Saline | 40.0 | 15 – 65 |
| Ropivacaine | 37.5 | 15.4 – 71.7 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04474366.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing