Opioid Sparing Pain Management Techniques for Gender Affirming Surgery
Palo Alto (17 mi)Overseen byMaurice M Garcia, M.D., MAS
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Cedars-Sinai Medical Center
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery. The purpose of this research is to determine if any of these options are more (versus less) effective than the others to manage surgery related pain, after surgery.
Is the treatment in the trial 'Opioid Sparing Pain Management Techniques for Gender Affirming Surgery' promising?Yes, the treatment is promising because using techniques like the Pecs II block can significantly reduce the need for opioids and lower pain levels after surgery, making recovery more comfortable and safer.257910
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for opioid-sparing pain management techniques in gender-affirming surgery?The safety data for opioid-sparing pain management techniques, such as ultrasound-guided nerve blocks, indicate that these methods are generally safe and effective for pain control. Studies on transversus abdominis plane (TAP) blocks and pudendal nerve blocks show that ultrasound guidance improves accuracy and safety by allowing visualization of anatomical structures. In a case series of pudendal nerve blocks for urethroplasty, patients experienced well-controlled pain with minimal complications. Similarly, TAP blocks have been successfully used in various surgical contexts, including abdominal and inguinal operations, with good anesthetic outcomes and minimal adverse effects.13568
What data supports the idea that Opioid Sparing Pain Management Techniques for Gender Affirming Surgery is an effective treatment?The available research shows that some of the techniques used in Opioid Sparing Pain Management, like the pudendal nerve block, have been effective in controlling pain for other surgeries. For example, in a study involving male patients undergoing urethroplasty, two out of three patients reported well-controlled pain after receiving a pudendal nerve block. Additionally, the transversus abdominis plane (TAP) block has been used successfully to manage pain after abdominal surgeries, as it numbs the nerves in the abdominal wall. These examples suggest that similar techniques could be effective for managing pain in gender-affirming surgeries.34568
Eligibility Criteria
This trial is for transgender individuals aged 18 or older who are undergoing gender-affirming surgeries with specific doctors. It's not for those with contraindications to study drugs, implanted pain devices, non-English speakers, or anyone unable to sense pain due to neurological deficits.Treatment Details
The study compares different opioid-sparing pain management techniques after gender-affirming surgery. Techniques include various nerve blocks and local anesthetics like Bupivacaine, aiming to find the most effective method for reducing post-operative pain.
3Treatment groups
Active Control
Group I: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1Active Control7 Interventions
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the pre-incision, intra-op, mid-surgery, end of surgery, or continuous time points:
* Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord)
* Local anesthetic (0.25% or 0.5% bupivacaine + 1:200K epinephrine)
* Bilateral ultrasound guided pudendal nerve block (20-40 cc of 0.25% bupivacaine + 1:200K epinephrine)
* Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
* Ultrasound guided Continuous Femoral Nerve Block
* Pecs I \& II Block (0.25% bupivacaine: 15-30ml per side for Pecs I-III)
Group II: Surgery-specific general anesthetic + local anesthetic at incision siteActive Control3 Interventions
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the mid-surgery or end of surgery time points:
* Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord)
* Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)
Group III: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2Active Control3 Interventions
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the intra-op, post-op, or end of surgery time points:
* Bilateral ultrasound-guided Transversus Abdominis Plane Block (40-60cc of 0.25% bupivacaine with 1:200K epinephrine)
* Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cedars-Sinai Medical Center - North and South TowersLos Angeles, CA
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Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
References
[Case of inguinal hernia repair with transversus abdominis plane block and rectus sheath block]. [2022]Transversus abdominis plane block is effective for lower abdominal and inguinal operations, and rectus sheath block is effective for abdominal operations. Recently, ultrasound guided nerve block has been employed, and these techniques can be performed with ultrasound scanning. An 82-year-old man with severe coronary failure and chronic obstructive pulmonary disease was scheduled for inguinal hernia repair. We did not want to select general anesthesia for him, and performed rectus sheath block and transversus abdominis plane block. We achieved good anesthetic management using two peripheral blocks under ultrasound scanning.
Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. [2022]Ultrasound-guided transversus abdominis plane (TAP) block has shown promise for analgesia after pediatric inguinal surgery. This prospective, randomized study tested the hypothesis that the TAP block would provide comparable analgesia after pediatric inguinal surgery compared with a conventional ultrasound-guided ilioinguinal block.
Effective dermatomal blockade after subcostal transversus abdominis plane block. [2018]The ultrasound-guided transversus abdominis plane (TAP) block is used to treat postoperative pain after abdominal surgery. Abdominal wall sensory nerves are anaesthetised by injecting local anaesthetics into the neurofascial plane between the internal oblique and the transversus abdominis muscles. Sensory assessment of a TAP block may guide the decision on the extent of the block. The purpose of this study was to investigate if the dermatomal extent of sensory blockade after injection of 20 ml 0.5% ropivacaine bilaterally into the TAP can be assessed using cold and pinprick sensation.
[Bilateral transversus abdominis plane block using catheterization for a patient with severe cardiac dysfunction and chronic kidney failure: a case report]. [2013]The transversus abdominis plane (TAP) block is a newly described technique introducing a local anesthetic agent between the internal oblique and the transversus abdominis muscles of the abdominal wall, which is safer and more reliable analgesia in recent years by ultrasound technique. We report the perioperative management of transversus abdominis plane block with catheterization for a patient with severe cardiac dysfunction and chronic kidney failure, who underwent bilateral inguinal hernioplasty. A bilateral TAP block was first performed with 0.5% ropivacaine 20 ml under ultrasonographic visualization on right side, and after sixty-minutes the other side injection was performed through the indwelling catheter. During the operation, the patient received a target-controlled infusion of 0.4-0.6 microg x ml(-1) propofol. The perioperative courses were uneventful and there was no adverse effect including central nervous system (CNS) symptoms.
Ultrasound-guided transversus abdominis plane injection with computed tomography correlation: a cadaveric study. [2022]Ultrasound-guided transversus abdominis plane (TAP) injections are increasingly being used as an alternative to traditional perioperative analgesia in the abdominal region. With the use of a "blind" TAP block technique, these procedures have had variable success in cadaver and in vivo studies. For more accurate injection with the intended medication, ultrasound guidance allows visualization of the correct layer of the abdominal wall planes in which the thoracolumbar nerves reside.
Pudendal nerve blocks in men undergoing urethroplasty: a case series. [2020]The pudendal nerve block (PNB) is widely used for regional anesthesia during obstetric and anorectal procedures, but its role in urologic procedures has not been thoroughly studied. While transvaginal PNB is relatively straightforward, PNB in male patients often requires imaging guidance due to difficulty appreciating anatomic landmarks. We review the PNB and relevant sonoanatomy, and describe its analgesic efficacy in three male patients undergoing urethroplasty for urethral stricture. In this procedure, the patient was placed in lithotomy position, the ischial tuberosity was palpated, and the sacrotuberous ligament and pudendal artery were identified using ultrasound. Ropivacaine was injected medial to the pudendal artery and disappearance of muscle twitch was demonstrated. Two patients reported well-controlled pain at 24 hours postoperatively. One reported perineal pain requiring additional analgesia. All patients were discharged on postoperative day 1 without complications. Ultrasound-guided PNB provides safe and reasonably effective pain control to male patients undergoing urologic procedures.
Comparison of ultrasound-guided posterior transversus abdominis plane block and lateral transversus abdominis plane block for postoperative pain management in patients undergoing cesarean section: a randomized double-blind clinical trial study. [2022]Due to the importance of pain control after abdominal surgery, several methods such as transversus abdominis plane (TAP) block are used to reduce the pain after surgery. TAP blocks can be performed using various ultrasound-guided approaches. Two important approaches to do this are ultrasound-guided lateral and posterior approaches. This study aimed to compare the two approaches of ultrasound-guided lateral and posterior TAP blocks to control pain after cesarean section.
Ultrasound-guided lateral and subcostal transversus abdominis plane block in calves: a cadaveric study. [2018]To describe and assess the ultrasound-guided transversus abdominis plane (TAP) block feasibility in calf cadavers, to compare two injection volumes and to evaluate possible undesired solution spreads.
Combined ultrasound-guided Pecs II block and general anesthesia are effective for reducing pain from modified radical mastectomy. [2020]Purpose: Combined regional and general anesthesia are often used for the management of breast cancer surgery. Thoracic spinal block, thoracic epidural block, thoracic paravertebral block, and multiple intercostal nerve blocks are the regional anesthesia techniques which have been used in breast surgery, but some anesthesiologists are not comfortable because of the complication and side effects. In 2012, Blanco et al introduced pectoralis nerve (Pecs) II block or modified Pecs block as a novel approach to breast surgery. This study aims to determine the effectiveness of combined ultrasound-guided Pecs II block and general anesthesia for reducing intra- and postoperative pain from modified radical mastectomy. Patients and methods: Fifty patients undergoing modified radical mastectomy with general anesthesia were divided into two groups randomly (n=25), to either Pecs (P) group or control (C) group. Ultrasound-guided Pecs II block was done with 0.25% bupivacaine (P group) or 0.9% NaCl (C group). Patient-controlled analgesia was used to control postoperative pain. Intraoperative opioid consumption, postoperative visual analog scale (VAS) score, and postoperative opioid consumption were measured. Results: Intraoperative opioid consumption was significantly lower in P group (P≤0.05). VAS score at 3, 6, 12, and 24 hrs postoperative were significantly lower in P group (P≤0.05). Twenty-four hours postoperative opioid consumption was significantly lower in P group (P≤0.05). There are no complications following Pecs block in both groups, including pneumothorax, vascular puncture, and hematoma. Conclusion: Combined ultrasound-guided Pecs II block and general anesthesia are effective in reducing pain both intra- and postoperatively in patients undergoing modified radical mastectomy. Ultrasound-guided Pecs II block is a relatively safe peripheral nerve block.
The Effect of Pectoral Nerve Blocks on Opioid use and Postoperative Pain in Masculinizing Mastectomy: A Randomized Controlled Trial. [2023]Bilateral masculinizing mastectomy is the most common gender affirmation operation performed. Currently, there is lack of data regarding intraoperative and postoperative pain control for this population. It is our aim to study the effects of the Pecs I and II regional nerve blocks in patients undergoing masculinizing mastectomy.