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GAMA
Paravertebral Versus Wide Local Infiltration for Analgesia Following Gender Affirming Mastectomy: A Randomized Controlled Trial.
Sponsor study identifier
interventional
64
1 country
1
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 14, 2026
Actual (reported)October 6, 2026
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Opioid consumption
Total opioid consumption (converted to oral morphine equivalents)
24 hours
Average pain score
24 hours
Time in Post Anesthesia Care Unit (PACU)
Time in PACU is measured from the patient entering the PACU until they are discharged to home or the hospital ward up to 12 hours. Time in PACU is approximately 2 hours on average, however longer times are possible.
Rate of postoperative nausea and vomiting (PONV)
Postoperative. This outcome will be assess up to 12 hours after arrival in PACU.
Quality of Recovery (QoR-15)
3 days
EuroQol five-dimensional questionnaire (EQ-5D)
3 days and 3 months
Local anesthetic placed by the surgeon
Paravertebral block placed by anesthesiologist under ultrasound
The regional anesthesiologist or fellow will place the paravertebral nerve block in the block room. The patient will be placed in prone position. Before any nerve block, a subcutaneous injection of lidocaine 1% is performed to numb the skin before insertion of the block needle. The block will be US-guided, using a 22g echogenic block needle to deliver a total of 20ml of ropivacaine 0.5% on each side into the paravertebral space. The paravertebral space will be identified by visualizing the transverse processes, the associated ribs, the costotransverse ligament, and observing pleural depression with injection of the local anesthetic. The level of the paravertebral block will be left to the discretion of the regional anesthesiologist (but T3-5 would be most common for anterior chest wall procedures).
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Anger JT, Case LK, Baranowski AP, Berger A, Craft RM, Damitz LA, Gabriel R, Harrison T, Kaptein K, Lee S, Murphy AZ, Said E, Smith SA, Thomas DA, Valdes Hernandez MDC, Trasvina V, Wesselmann U, Yaksh TL. Pain mechanisms in the transgender individual: a review. Front Pain Res (Lausanne). 2024 Mar 27;5:1241015. doi: 10.3389/fpain.2024.1241015. eCollection 2024.
Singh NP, Makkar JK, Kuberan A, Guffey R, Uppal V. Efficacy of regional anesthesia techniques for postoperative analgesia in patients undergoing major oncologic breast surgeries: a systematic review and network meta-analysis of randomized controlled trials. Can J Anaesth. 2022 Apr;69(4):527-549. doi: 10.1007/s12630-021-02183-z. Epub 2022 Jan 31.
First Submitted
September 14, 2026
First Posted
October 6, 2026
Ropivacaine 0.5% is used for wide local infiltration anesthesia in the comparison group at the conclusion of the procedure. Forty ml are used in total, and approximately 5ml is injected bilaterally into each of the superomedial, superolateral (into the pectoralis major muscle fascia), inferolateral (over the drain site), and inferomedial.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Katsnelson G, Brenna CTA, Giron-Arango L, Abdallah YM, Brull R. Analgesic benefits of regional anesthesia in the perioperative management of transition-related surgery: a systematic review. Reg Anesth Pain Med. 2025 May 6;50(5):441-448. doi: 10.1136/rapm-2024-105479.
Gran I, Kamali A, Granath F, Frisen L, Lindqvist EK, Dhejne C, Sommar P, Sackey H. Improved health-related quality of life and gender congruence after gender-affirming mastectomy-a prospective cohort study. J Sex Med. 2025 Oct 5;22(10):1882-1890. doi: 10.1093/jsxmed/qdaf203.
Lane M, Kirsch MJ, Sluiter EC, Svientek SR, Hamill JB, Morrison SD, Ives GC, Alman E, Gilman RH, Kuzon WM, Cederna PS, Wilkins EG. Gender Affirming Mastectomy Improves Quality of Life in Transmasculine Patients: A Single-center Prospective Study. Ann Surg. 2023 Mar 1;277(3):e725-e729. doi: 10.1097/SLA.0000000000005158. Epub 2021 Aug 13.
Sivakumar S, Kressel A, Mendonca R, Girshin M. Battle of the Blocks: Which Pain Management Technique Triumphs in Gender-Affirming Bilateral Mastectomies? J Clin Med Res. 2024 Jun;16(6):284-292. doi: 10.14740/jocmr5159. Epub 2024 Jun 18.
Jackman L, Chan C, Garvilles M, Kamran R. Outcome measurement for gender-affirming care in Canada: a systematic review. BMJ Open. 2025 Mar 12;15(3):e091135. doi: 10.1136/bmjopen-2024-091135.
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 6, 2026
Record last verified: 2026-09
For protection of patient privacy
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Source: ClinicalTrials.gov.
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