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

Pending

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.

2024-01-01

2024-06-30

2024-09-30

Early phase I

15

Inclusion Criteria: 1. Age 18-80 2. Patients undergoing laparoscopic or robotic hysterectomy; may include other procedures (e.g. lymph node removal) 3. Endometrial cancer or endometrial intraepithelial neoplasia 4. Able to consent to study Exclusion Criteria: 1. Known clinically significant allergy to bupivacaine or liposomal bupivacaine 2. ASA IV or V 3. Emergency surgery 4. Current chronic opiate use 5. Current pregnancy or breastfeeding 6. Severe hepatic or renal impairment 7. Hysterectomy is not for endometrial cancer or endometrial intraepithelial neoplasia

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Potential subjects will be identified in the GYN specialty clinics at Tufts Medical Center and approached for possible study participation. Eligibility criteria will be assessed by the PI or co-I. Eligible subjects who wish to participate in the study will be consented for the study by the PI or co-I. Informed consent for the study may be obtained up to the day of the surgery, prior to anesthesia induction. The following demographics will be collected from the medical record and de-identified: age, race, ethnicity, height, weight, ASA class.\n\nOn the day of surgery, the subject will be randomized using a random number generator to one of 3 groups:\n\n1. No TAP block\n2. TAP block with liposomal and plain bupivacaine: 20 mL liposomal bupivacaine, 30 mL 0.25% bupivacaine, 150 mL normal saline (200 mL total)\n3. TAP block with plain bupivacaine alone: 60 mL of 0.25% bupivacaine, 140 mL of normal saline (200 mL total)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The pharmacy will prepare the solutions for groups 2 and 3, reflecting the usual practice of this PI and his mentees. No solution will be prepared for group 1, as this is a form of standard care for patients undergoing minimally invasive hysterectomy. As the liposomal bupivacaine has a cloudy appearance whereas plain bupivacaine and saline are clear, the surgeon will not be blinded.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

2024-02-02