[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659143":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":53,"studyPopulation":41,"armGroups":54,"interventions":67,"overallOfficials":41,"centralContacts":77,"locations":87,"responsibleParty":102,"collaborators":41,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":41,"enrollmentInfo":116,"targetDuration":41,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":131,"whyStopped":41,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Opioid consumption","Total opioid consumption (converted to oral morphine equivalents)","24 hours",[14,17,21,25,29,33,37],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"Time in Post Anesthesia Care Unit (PACU)","Time in Post Anesthesia Care Unit (PACU) measured in minutes","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.",{"measure":22,"description":23,"timeFrame":24},"Rate of postoperative nausea and vomiting (PONV)","Postoperative nausea and vomiting (PONV) as determined by the recovery room nurses. Documented in the chart.","Postoperative. This outcome will be assess up to 12 hours after arrival in PACU.",{"measure":26,"description":27,"timeFrame":28},"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).","3 days",{"measure":30,"description":31,"timeFrame":32},"EuroQol five-dimensional questionnaire (EQ-5D)","EuroQol five-dimensional questionnaire (EQ-5D) is a questionnaire used to measure health related quality of life across five dimensions (mobility, self-care, usual activities, pain\u002Fdiscomfort, anxiety\u002Fdepression). The EQ-5D-3L is a version of the EQ-5D that measures each dimension across three levels of severity. The EQ-5D is scored using index value set calculators to assign a numeric value where 0 is equivalent to being dead and 1 is perfect health. It is possible to have scores that are below zero indicating a state worse than being dead.","3 days and 3 months",{"measure":34,"description":35,"timeFrame":36},"Persistent postsurgical pain","At 3 months following the procedure date, the patient will be asked about persistent post-surgical pain based on the Brief Pain Inventory (BPI). There are 7 pain interference items included in the BPI. Pain interference as measured by the BPI will be calculated by averaging the 7 pain interference items. Pain severity is measured by averaging 4 pain severity items. Each item is scored on an 11-point Likert scale from 0 to 10 such that the averages indicate no pain interference\u002Fseverity at 0 and maximum pain interference\u002Fseverity at 10.","3 months",{"measure":38,"description":39,"timeFrame":40},"Postoperative complications","The following block related complications will be recorded: local anesthetic systemic toxicity, pneumothorax, bleeding, or anaphylaxis.\n\nThe following adverse event data recorded in the participant's chart will be captured by the research coordinator following 7 postoperative days: pneumonia, respiratory failure, wound infection, sepsis, arrhythmias, readmission to hospital, and hospital mortality. Complications will be categorized by severity using the Clavien-Dindo (CD) classification: nonfatal complications will be defined as minor (CD level I and II) and major (CD level III and IV), and fatal complications will be categorized as CD level V. If a patient experiences more than one complication, the most severe will be used for analysis.","7 days",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":48,"whoMasked":49},"TRIPLE","The allocation will be masked to the patient, the recovery room staff, and the assessors.\n\nIt is not possible to mask the allocation for the anesthesiologists and surgeons without the use of placebo nerve block injections.\n\nTo conceal allocation to the WLI group, the patient will be brought to the block room, and a simulated block will be performed. The patient will be positioned for a paravertebral block, standard monitors applied, and their back will be scanned with an ultrasound machine to show the ultrasound views for a paravertebral block. However, no block needle will be inserted. Instead, finger pressure at the injection area will simulate the pressure of a needle being inserted.\n\nWLI occurs under anesthesia, so simulated blocks to conceal allocation is not needed for the patient or assessors in the paraverteral group.",[50,51,52],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","In Canada, there has been a rise in the number of transgender and gender-diverse individuals seeking gender-affirming care in recent years. Canada has seen roughly a ten-fold increase in gender-affirming care referrals over the past decade.\n\nA gender-affirming mastectomy (GAM), also called top surgery, is one potential intervention for trans men and non-binary individuals. This procedure entails bilateral mastectomy with chest contouring to create a masculine-appearing chest. This operation is life-changing for many as it can alleviate gender dysphoria and improve mental health and quality of life.\n\nA significant clinical issue in GAM is postoperative pain management. These procedures involve large incisions across the chest and tissue excision, and as such, pain can be significant. With only a few other studies focused on our target population, evidence on effective pain management strategies in this population is limited, and many nerve block types have not been studied.\n\nA wide body of research focuses on nerve block use for oncological mastectomies. Network metanalysis has recognized continuous paravertebral nerve blocks as the most effective regional anesthesia technique, while wound infiltration is only slightly better than no intervention. Oncological research recognizes the ability of continuous paravertebral nerve blocks to provide prolonged analgesia and decrease opioid consumption. That said, there are some concerns about directly applying this knowledge to individuals having a mastectomy due to gender-affirming purposes. Patients undergoing GAM are often young and healthy without comorbidities that many breast cancer patients have. Additionally, many breast cancer patients undergo axillary lymph node dissection, which can increase post-operative pain There is also research that indicates that chronic testosterone administration, which applies to much of this population, increases pain thresholds, which could have potential impacts on the analgesic requirements for these patients. Many seeking mastectomies due to gender-affirming purposes have a positive outlook on the operation in comparison to patients having a mastectomy due to breast cancer. This may alter their pain perception. Notably, some research indicates stressors, such as those caused by gender dysphoria, may exacerbate pain. These differences between the patient populations' pain profiles make this research necessary to better understand this supplemental analgesia technique in gender-affirming care.\n\nPrimary Study Objective The primary objective is to determine whether paravertebral nerve blocks are superior to wide local infiltration in terms of decreased opioid consumption (oral morphine equivalents) in the first 24 postoperative hours for people undergoing GAM.\n\nSecondary Objectives\n\nDetermine whether paravertebral nerve blocks are superior to wide local infiltration after GAM for:\n\n* Average pain score in the first 24 hours\n* Time in Post Anesthesia Care Unit (PACU)\n* Postoperative nausea and vomiting (PONV) in PACU\n* Quality of Recovery (QoR-15) at 3 days\n* EuroQol five-dimensional questionnaire (EQ-5D) at 3 days and 3 months\n* Persistent postsurgical pain (brief pain inventory) at 3 months\n* Postoperative complications with first 7 postoperative days\n\nResearch questions RQ1: Does the use of paravertebral nerve blocks, as compared to wide local infiltration, reduce opioid consumption within the first 24 hours following gender-affirming mastectomy? RQ2: What is the trajectory of pain and opioid use in the 72 hours following gender-affirming mastectomy? RQ3: Does the use of paravertebral nerve blocks, as compared to wide local infiltration, improve other postoperative patient centered outcomes (pain at 24 hours, PONV, QoR-15, EQ-5D, long-term pain)?\n\nMethods This study will include patients undergoing gender affirming bilateral mastectomy at the QEII Health Sciences Center in Halifax, Nova Scotia.\n\nNumber of participants The study will include a maximum of 64 participants, randomly assigned to 2 study arms of 32 participants (paravertebral or wide local infiltration). The patients will be consented and screened at least 1 day before their surgery.\n\nRandomization and concealment Patients who have consented to the study, will be randomly assigned into two groups. A computer-generated online randomization software will be used to randomize patients on a 1:1 basis to the paravertebral block (PVB) or the wide local infiltration (WLI) groups. The patient will either receive a paravertebral nerve block by anesthesiology in the block room versus wide local infiltration by the surgeon. Patients randomized to the PVB group will receive the block as per protocol, while those in the WLI group will undergo simulated block procedures using ultrasound and applied pressure to mimic the experience. The study data will be analyzed as per intention-to-treat.\n\nStandardized Anesthesia technique Intravenous access and monitors typical at our institution including peripheral intravenous cannula(s), temperature probe and standard Canadian Anesthesiologists' Society (CAS) monitors (electrocardiography, pulse oximeter, and non-invasive blood pressure) will be applied. Induction and maintenance medication will be left to the discretion of the attending anesthesiologist with some exceptions. Lidocaine infusions will not be permitted in study patients. These medications are rarely used intraoperatively in plastic surgery and may increase the risk of LAST if given near the time of a block. Opioid administration intraoperatively and postoperatively will be administered at the discretion of the treating team. Use of intravenous dexamethasone will be encouraged unless contraindicated.\n\nPostoperative care The standard of care for pain management for this patient population is opioid based (fentanyl, morphine, hydromorphone) with acetaminophen. The opioid medications are ordered as intermittent doses either injected intravenously, subcutaneously or ingested orally in the PACU. Codeine prescriptions will not be permitted due to their inconsistent conversion to morphine.\n\nRegardless of group allocation, patients will receive all the usual pain medications they normally would in the postoperative period.\n\nData collection procedure Baseline data\n\nA research coordinator (RC) will collect the baseline data as outlined below at the time of recruitment to the study:\n\n* Age, sex assigned by birth, self-identified gender, body mass index (BMI), preoperative pain medication, comorbidities (respiratory disease, cardiac disease, kidney disease, liver disease, prior stroke, seizure disorders)\n* Pre-existing pain (Brief pain inventory)\n* Cannabis use within the last month on average (route (inhaled versus ingested), frequency, dose). Routine or high dose cannabis use is known to be associated with high postoperative pain scores.\n* American Society of Anesthesiologists' (ASA) classification.\n* Testosterone dosing and route (if applicable)\n\nPostoperative data Participants will be provided with a journal to track their postoperative data. Then at 3 days, 7 days, and 3 months participants will be emailed a survey hosted on Research Electronic Data Capture (REDCap) to share their recovery.\n\nAny patient that would prefer to have the surveys completed over the phone can request this and a member of the research team will call them on day 1, 2, 3, and 7; then 3 months post operatively. Survey responses can be stored in the patient's pain journal for questions that would have been asked at earlier timeframes (e.g., 24 hours) to match the data collected from the those completing the surveys online.\n\nStatistical analysis Primary and secondary analyses Numerical outcomes from RQ1 and RQ3 will be tested using a Welch t-tests with condition as a predictor of various outcomes (24hr opioid use, 24hr pain, QoR-15, EQ-5D, and persistent pain at 3 months). The categorical outcome (PONV) will be analyzed using a chi-squared test of independence. Trajectories of pain and opioids over the first 72hrs (RQ2) will be analyzed using linear mixed models; the investigators will explore both linear and quadratic models for rates of change over time. Linear mixed models will be used in a similar fashion to assess trajectories of change in gender congruence at 4 time points (baseline, day 3, day 7, and 3 months).\n\nIn all cases, the investigators will include all patients as an intention-to-treat protocol, using data when it is available for each outcome (even if data is missing from other outcomes). To address missing data, multiple imputation will be used, as it is a gold standard method for handing missingness.",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"Wide local infiltration (WLI)","ACTIVE_COMPARATOR","Local anesthetic placed by the surgeon",[60],"Procedure: Wide local infiltration",{"label":62,"type":63,"description":64,"interventionNames":65},"Paravertebral (PVB)","EXPERIMENTAL","Paravertebral block placed by anesthesiologist under ultrasound",[66],"Procedure: Paravertebral (single injection)",[68,73],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":41},"PROCEDURE","Paravertebral (single injection)","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).",[62],{"type":69,"name":74,"description":75,"armGroupLabels":76,"otherNames":41},"Wide local infiltration","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.",[56],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":41,"email":82},"Jonathan G Bailey","CONTACT","902-473-4326‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬","jon.bailey@nshealth.ca",{"name":84,"role":80,"phone":85,"phoneExt":41,"email":86},"Joseph Corkum","902-473-6316","JosephP.Corkum@nshealth.ca",[88],{"facility":89,"status":41,"city":90,"state":91,"zip":41,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"QEII Health Sciences Centre","Halifax","Nova Scotia","Canada","CA",{"type":95,"coordinates":96},"Point",[97,98],-63.57688,44.64269,{"lat":98,"lon":97},[101],{"name":79,"role":80,"phone":81,"phoneExt":41,"email":82},{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Jon Bailey","Anesthesiologist, Associate Professor","100659143","gender-affirming-mastectomy-analgesia-rial-100659143",false,"NCT07861165","Gender Affirming Mastectomy Analgesia Rial","Paravertebral Versus Wide Local Infiltration for Analgesia Following Gender Affirming Mastectomy: A Randomized Controlled Trial.","GAMA","Inclusion Criteria:\n\n* Adult (aged \\>18 years) patients\n* Undergoing gender affirming bilateral mastectomy\n* Self-identifying with gender dysphoria\n\nExclusion Criteria:\n\n* Severe pre-existing liver disease (Child B or C)\n* Severe kidney disease (Glomerular filtration rate (GFR) \\\u003C30 (mL\u002Fmin\u002F1·73m²))\n* Severe lung disease (modified Medical Research Council Dyspnea Scale \\> 2)\n* An allergy to ropivacaine\n* Weight \\\u003C50 kg\n* Unable to provide valid consent to study prior to surgery\n* BMI\\>45\n\nJustification for exclusion criteria Patients being excluded for liver disease, kidney disease, and low weight decreases the risk of local anesthetic systemic toxicity. Known allergy to ropivacaine (the local anesthetic used in both groups) is to avoid anaphylaxis or other serious allergic reaction. Both types of blocks have a low risk of pneumothorax (injury to the lung); hence excluding patients with severe lung disease. Higher BMI (due to excess adipose tissue) increases the difficulty of nerve blocks, which could both increase risks and decrease success rates. Inability to provide consent interferes with the consent process. While a caregiver could provide consent on behalf the patient, the patient would not be able to complete self-rated scores, which are the central outcomes of this study.","ALL","19 Years",{"count":117,"type":118},64,"ESTIMATED","INTERVENTIONAL",[121],"NA","Introduction:\n\nOptimizing 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.\n\nResearch question:\n\nDoes 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?\n\nHypothesis:\n\nThe 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.\n\nMethodology:\n\nThis 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.",[124,125,126],"Gender Affirming Surgery","Mastectomy","Acute Pain",[128,129,130],"gender affirming mastectomy","regional anesthesia","nerve block","NOT_YET_RECRUITING","2026-10-01",{"date":134,"type":135},"2026-10-06","ACTUAL",{"date":137,"type":118},"2027-01-01",{"date":139,"type":118},"2029-11-01",{"name":5,"class":6},1]