At a glance
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A Randomized, Controlled, Observer-blinded Pilot Trial of Laparoscopic Large Volume, Multisite Transversus Abdominal Plane (TAP) Block With Liposomal Bupivacaine in Patients Undergoing Minimally Invasive Hysterectomy for Endometrial Cancer
In Brief
A Phase 3 clinical trial evaluating Liposomal bupivacaine and Bupivacain for Post Operative Pain and Gynecologic Cancer. Completed, enrolled 15 participants across 1 site.
Detailed Summary
Modern postoperative pain management aims to optimizing pain relief while minimizing opiate usage. While opiates are effective for pain relief, they result in common adverse effects such as nausea, constipation, and urinary retention, and most importantly present a long-term risk of abuse and dependency. Commonly used approaches include non-opiate pain medications such as acetominophen and non-steroidal anti-inflammatory agents, as well as regional nerve blocks such as epidurals. The transversus abdominis plane (TAP) block is a fascial plane block performed by injecting local anesthetic into the plane superficial to the transversus abdominis muscle where the anterior rami of the spinal nerves course to provide sensory innervation to the abdominal wall. The injections are generally placed either subcostally or at the midaxillary line bilaterally. The TAP block has been shown to be effective in reducing pain scores and opiate usage in some randomized studies but not others in patients undergoing various abdominal surgeries. There is great variation in method of administration, sites injected, and local anesthetics used, which may in part account for the heterogeneity of trial results.
Study Details
Timeline
Interventions
Liposomal bupivacaine is FDA-approved for use single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. The solution will be placed into 20 mL syringes on 18-gauge needles for injection. The injections will be performed percutaneously by the surgeon along the midaxillary line at 4 equidistant points from the anterior superior iliac spine to the costal margin, as well as a single injection subcostally at the anterior axillary line. 20 mL will be injected at each site, 5 sites per side bilaterally, total of 10 sites. The depth of injection will be judged by laparoscopic visualization of a diffuse bulge during injection, indicating injection in the correct plane, just superficial to the transversus abdominis muscle.
Bupivacaine is FDA-approved for use as a local or regional anesthetic for surgery. It is widely used in TAP blocks. The solution will be placed into 20 mL syringes on 18-gauge needles for injection. The injections will be performed percutaneously by the surgeon along the midaxillary line at 4 equidistant points from the anterior superior iliac spine to the costal margin, as well as a single injection subcostally at the anterior axillary line. 20 mL will be injected at each site, 5 sites per side bilaterally, total of 10 sites. The depth of injection will be judged by laparoscopic visualization of a diffuse bulge during injection, indicating injection in the correct plane, just superficial to the transversus abdominis muscle.