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NCT05763667CompletedPhase 3

Pilot: Intraoperative TAP Block and Post-operative Pain Control for Minimally Invasive Hysterectomy for Endometrial Cancer

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

Source: ClinicalTrials.gov · Last updated 24 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
15 (actual)
First submitted
28 Feb 2023
Start date
1 Jan 2024
Primary completion date
1 Jul 2024
Lead sponsor
Tufts Medical Center
NCT number
NCT05763667

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 15
  • From 1 Jan 2024 to the primary completion date, 1 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Emergency surgery

Other illness

  • Known clinically significant allergy to bupivacaine or liposomal bupivacaine
  • Severe hepatic or renal impairment
  • Hysterectomy is not for endometrial cancer or endometrial intraepithelial neoplasia

Other

  • ASA IV or V
  • Current chronic opiate use
  • Current pregnancy or breastfeeding

Who the study is looking for

  • Age 18-80
  • Patients undergoing laparoscopic or robotic hysterectomy; may include other procedures (e.g. lymph node removal)
  • Endometrial cancer or endometrial intraepithelial neoplasia
  • Able to consent to study

Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Tufts Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.