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
- Diseases
- Endometrial cancer
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.