Comparing the Effect of TAP-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery

Not Applicable

Withdrawn

• Conditions: Pain, Postoperative
• Interventions: Drug: Ropivacaine bolus in transversus abdominis plane catheter; Drug: Bupivacain-infusion in epidural catheter

• Registration Number: NCT01760174
• Lead Sponsor: Aalborg University Hospital

Brief Summary

This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. The hypothesis is that the effect of the two modes of pain treatment are equal.

Detailed Description

Patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:TAP) catheters. After randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the TAP-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the TAP-catheters and bupivacain-infusion in the epidural catheters.

The investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12.

The investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.

Study Timeline

• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12
• Study Start: 2016-01
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients scheduled for open gynecologic surgery
• acceptance to participate

Exclusion Criteria

• allergies to local analgetics
• daily use of strong opioids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine bolus in transversus abdominis plane catheter	Ropivacaine bolus in transversus abdominis plane catheter	Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter.
Bupivacain-infusion in epidural catheter	Bupivacain-infusion in epidural catheter	Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter.

Primary Outcome Measures

Name	Time	Method
Pain-score on numerical rating scale	4 hours after first bolus in tranversus abdominis catheters

Secondary Outcome Measures

Name	Time	Method
Administration of opioids	The first 24 hours after surgery.
Pain-score on numerical rating scale	24 hours after first bolus in tranversus abdominis catheters

Trial Locations

Locations (1)

Aalborg Hospital; 🇩🇰 Aalborg, Region Nord, Denmark