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

NCT04474366 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-28267
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Comparison of Post Operative Pain Scores

  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.

  1 week post operative

Secondary Outcomes (2)

• Comparison of Intra Operative Narcotic Requirements

  Intraoperative

• Comparison of Post Operative Narcotic Requirements

  1 week post operative

Study Arms (2)

Saline

SHAM COMPARATOR

Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.

Other: Saline (0.9%)

Ropivacaine

EXPERIMENTAL

Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).

Drug: Ropivacaine 0.2% Injectable Solution

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

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

Ropivacaine

Saline (0.9%) OTHER

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

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) class I-III
• Ages 18-65
• Undergoing gender confirmation breast reduction surgery by a single surgeon at a single center

You may not qualify if:

• Previous breast surgeries
• Current breast cancer or history of treatment for breast cancer
• Current chronic pain syndromes
• Coagulopathy
• Allergy to local anesthetics
• Infection at the injection site

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

• Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

  PMID: 25376971 BACKGROUND

• M N, Pandey RK, Sharma A, Darlong V, Punj J, Sinha R, Singh PM, Hamshi N, Garg R, Chandralekha C, Srivastava A. Pectoral nerve blocks to improve analgesia after breast cancer surgery: A prospective, randomized and controlled trial. J Clin Anesth. 2018 Mar;45:12-17. doi: 10.1016/j.jclinane.2017.11.027. Epub 2017 Dec 11.

  PMID: 29241077 BACKGROUND

• Benotsch EG, Zimmerman R, Cathers L, McNulty S, Pierce J, Heck T, Perrin PB, Snipes D. Non-medical use of prescription drugs, polysubstance use, and mental health in transgender adults. Drug Alcohol Depend. 2013 Sep 1;132(1-2):391-4. doi: 10.1016/j.drugalcdep.2013.02.027. Epub 2013 Mar 17.

  PMID: 23510637 BACKGROUND

• Day JK, Fish JN, Perez-Brumer A, Hatzenbuehler ML, Russell ST. Transgender Youth Substance Use Disparities: Results From a Population-Based Sample. J Adolesc Health. 2017 Dec;61(6):729-735. doi: 10.1016/j.jadohealth.2017.06.024. Epub 2017 Sep 21.

  PMID: 28942238 BACKGROUND

• Wallace AB, Song S, Yeh P, Kim EA. The Effect of Pectoral Nerve Blocks on Opioid Use and Postoperative Pain in Masculinizing Mastectomy: A Randomized Controlled Trial. Plast Reconstr Surg. 2024 Mar 1;153(3):570-577. doi: 10.1097/PRS.0000000000010707. Epub 2023 May 23.

  PMID: 37220393 DERIVED

MeSH Terms

Conditions

Gender Dysphoria; Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Esther Kim
• Organization: University of California, San Francisco

Esther.kim@ucsf.edu

415-353-9392

Study Officials

• Esther Kim, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 16, 2020
• Study Start: June 16, 2020
• Primary Completion: February 28, 2022
• Study Completion: April 30, 2022
• Last Updated: July 3, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data. For any purpose.

Locations

US (1)