CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
TAP Block with Bupivicaine +1 moreprocedure
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/NCT03443271
NCT03443271Phase 4Completed

Effect of Transversus Abdominis Plane (TAP) Block and the Perioperative Stress Response: Randomized Control Trial in Patient Undergoing Total Abdominal Hysterectomy in a Tertiary Care Hospital of Pakistan

Aga Khan University·interventional·Posted Feb 23, 2018·Updated Feb 23, 2018

In Brief

A Phase 4 clinical trial evaluating TAP Block with Bupivicaine and TAP Block with Placebo drug for Abdominal Hysterectomy and Postoperative Pain. Completed, enrolled 50 participants.

Detailed Summary

Random allocation of patients in two groups; Tap block group (T group) and control group (C group). All patients will receive standard general anesthesia and postoperative pain management. The TAP group patient will receive ultrasound guided (US) TAP block with 20 cc of 0.25% of bupivacaine and control group will receive 20cc of normal saline. TAP block in both groups will be performed with US guidance and the study drug will be injected after complete visualization of the needle tip between the internal oblique and the transversus abdominis muscles. Venous blood samples (5 ml for each time) for metabolic and stress hormones, including, Serum cortisol and nor-epinephrine will be collected before anesthesia at the time of cannulation (T1),60 minutes after incision(T2), 6hrs (T3)and 12 h (T4) after the surgery. Postoperatively patient will be put on patient controlled intravenous infusion of nalbuphine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2018
Enrollment StartJun 17, 2016
Primary CompletionSep 19, 2017
Study CompletionSep 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.4 years ago

Interventions

TAP Block with Bupivicaineprocedure

Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.25 % Bupivicaine on each side.

TAP Block with Placebo drugprocedure

Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.9% Saline on each side.