Paravertebral Nerve Blocks vs Skin Freezing for Pain Management in Top Surgery

(GAMA Trial)

JG
JC
Overseen ByJoseph Corkum
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Introduction:

Optimizing pain management after gender-affirming mastectomy (removal of breast tissue, aka top surgery) surgery is important for recovery and minimizing opioid use. While paravertebral nerve blocks (numbing the chest wall through injections near the spine) and injection of local anesthetic ("skin freezing") are two commonly used methods, it's not clear which of these techniques is best among patients seeking gender-affirming care. Previous studies on nerve blocks in breast surgery have mostly concentrated on patients having breast cancer removed. Studies show that paravertebral blocks are superior to skin freezing in breast cancer surgery. However, it has not been established whether this reduces long-term pain and works similarly in gender-affirming top surgery. This study aims to compare the how well nerve blocks work comparing to skin freezing for pain and opioid use after surgery.

Research question:

Does the use of paravertebral nerve blocks, as compared to skin freezing (aka wide local infiltration), reduce need for opioid use within the first 24 hours following gender-affirming mastectomy?

Hypothesis:

The investigators hypothesize that paravertebral nerve blocks are superior to wide local infiltration in terms of reduced need for opioid consumption in the first 24 postoperative hours for gender-affirming mastectomy (GAM) patients.

Methodology:

This randomized control trial will include adult patients undergoing GAM. The patients will be randomly placed into the either the nerve block group or the skin freezing group. Patients who are in the skin freezing group will also be sent to the block room where they will receive ultrasound and pressure to mimic the feeling of receiving a block. Pain will be measured using the 0-10 Numeric Rating Scale, and opioid use will be recorded at 24-, 48-, and 72-hours post-op. Given that most patient leave hospital on the same day, participants will complete a pain journal at home and will be emailed an electronic survey to submit their results. Quality of recovery will be measured at 3 days after surgery. A follow-up survey at 3 months will assess longer term pain using the Brief Pain Inventory. Phone calls to complete the survey with a member of the research team can be done by request.

Are You a Good Fit for This Trial?

This trial is for adults having gender-affirming mastectomy (top surgery). Participants must be able to complete pain surveys after surgery. People who do not meet these criteria or have conditions that prevent safe participation will not be included.

Inclusion Criteria

I am over 18 years old.
I am having gender affirming surgery to remove both breasts.
I identify as having gender dysphoria.

Exclusion Criteria

Allergy to ropivacaine
Weight <50 kg
Unable to provide valid consent to study prior to surgery
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What Are the Treatments Tested in This Trial?

Interventions

  • Paravertebral Nerve Block
  • Wide Local Infiltration

Trial Overview

The study compares two ways of managing pain during top surgery: a paravertebral nerve block (numbing injection near the spine) versus wide local infiltration ('skin freezing' with numbing medicine under the skin). Patients are randomly assigned to one group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Paravertebral (PVB)Experimental Treatment1 Intervention
Group II: Wide local infiltration (WLI)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+