Gender Affirming Mastectomy Analgesia Rial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNova Scotia Health Authority
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (aged >18 years) patients
Undergoing gender affirming bilateral mastectomy
Self-identifying with gender dysphoria
Disqualifiers
Severe pre-existing liver disease (Child B or C)
Severe kidney disease (Glomerular filtration rate (GFR) <30 (mL/min/1·73m²))
Severe lung disease (modified Medical Research Council Dyspnea Scale > 2)
An allergy to ropivacaine
Trial design
Design model
Parallel
Treatments tested in this trial
Paravertebral (single injection)
Procedure/SurgeryThe 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).
Wide local infiltration
Procedure/SurgeryRopivacaine 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Wide local infiltration (WLI)Active comparator 1 intervention
Group B: Paravertebral (PVB)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Opioid consumption
Total opioid consumption (converted to oral morphine equivalents)
Time frame
24 hoursSecondary outcomes
1
Average pain score
Average pain score using the numerical rating scale (NRS) rated on a 0-10 scale with 0 being no pain and 10 being the worse pain imaginable.
Time frame
24 hours2
Time in Post Anesthesia Care Unit (PACU)
Time in Post Anesthesia Care Unit (PACU) measured in minutes
Time frame
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.3
Rate of postoperative nausea and vomiting (PONV)
Postoperative nausea and vomiting (PONV) as determined by the recovery room nurses. Documented in the chart.
Time frame
Postoperative. This outcome will be assess up to 12 hours after arrival in PACU.4
Quality of Recovery (QoR-15)
The quality of recovery (QoR-15) questionnaire is a patient-centered measure that includes five domains of recovery after surgery: patient support, comfort, emotions, physical independence, and pain. Each item is graded on a eleven-point Likert scale with QoR-15 scores ranging from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
Time frame
3 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: