drugset / Trial / NCT01866917

Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women

NCT01866917 ↗

Phase 1/2 Terminated 35 enrolled Montefiore Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.

Timeline

Start
2013-04
Primary completion
2016-04
Completion
2016-04

Outcome

Missed primary endpoint

Stopped: “Pharmacy stopped dispensing study medication”

registry analysis (superiority test); Transversus Abdominis Plane (TAP) Group B vs Saline Group A; p = .574; Chi-squared NCT01866917 ↗

registry analysis (superiority test); Transversus Abdominis Plane (TAP) Group B vs Saline Group A; p = .825; Interquartile range (IQR) 3; Chi-squared NCT01866917 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 0.5 % —
Subject Ropivacaine Other / unclassified 20 ml —

Indications

No indication recorded.