CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 148 enrolled
Drug / intervention
Bupivacain +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04426500
NCT04426500Phase 3Completed

Use of Perioperative Pain Blocks In Urological Surgery: A Phase III Randomized Single Blind Single Center Three Arm Non-inferiority Trial

Icahn School of Medicine at Mount Sinai·interventional·Posted Jun 11, 2020·Updated Mar 12, 2024

In Brief

A Phase 3 clinical trial evaluating Bupivacain, Ultrasound-guided transversus abdominus plane block, and 1 other intervention for Pain, Postoperative and 2 related conditions. Completed, enrolled 148 participants across 1 site.

Detailed Summary

The study team aims to prospectively compare Placebo (local administration), ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 11, 2020
Enrollment StartNov 11, 2019
Primary CompletionFeb 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.1 years ago

Interventions

Bupivacaindrug

Direct injection of 0.25% bupivacaine into surgical wounds

Ultrasound-guided transversus abdominus plane blockdrug

bilateral TAP using ultrasound guidance in prostatectomies

Laparoscopic-guided transversus abdominus plane blockdrug

bilateral TAP using laparoscopic guidance in prostatectomies