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

A Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Bupivacain-infusion in epidural catheter; Drug: Ropivacaine bolus in transversus abdominis plane catheter

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Nord
    • Aalborg, Region Nord, Denmark, 9000
      • Aalborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients scheduled for open gynecologic surgery
• acceptance to participate

Exclusion Criteria:

• allergies to local analgetics
• daily use of strong opioids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacain-infusion in epidural catheter; Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter.	Drug: Bupivacain-infusion in epidural catheter; Isotonic potassium chloride, 10-25 ml in each transversus abdominis catheter, depending on patient weight. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml bupivacaine 2,5 mg/ml is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours
Active Comparator: Ropivacaine bolus in transversus abdominis plane catheter; Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter.	Drug: Ropivacaine bolus in transversus abdominis plane catheter; Ropivacaine 7,5 mg/ml, 10-25 ml in each catheter, depending on patient weight, the total dose of ropivacaine is kept less than 3 mg/kg for every bolus. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml isotonic potassium chloride is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain-score on numerical rating scale	4 hours after first bolus in tranversus abdominis catheters

Secondary Outcome Measures

Outcome Measure	Time Frame
Administration of opioids	The first 24 hours after surgery.
Pain-score on numerical rating scale	8 hours after first bolus in tranversus abdominis catheters
Pain-score on numerical rating scale	24 hours after first bolus in tranversus abdominis catheters

Other Outcome Measures

Outcome Measure	Time Frame
Thermoanalgesia at dermatome-level th10-th12	4 hours after first bolus in TAP-catherter

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Nils F Bjerregaard, M.D., Aalborg University Hospital; Study Director: Bodil S Rasmussen, M.D. + PhD, Aalborg Sygehus; Study Chair: Lone Nikolajsen, M.D, PhD, Aarhus University Hospital; Study Chair: Thomas F Bendtsen, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Transversus abdominis plane catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: N-20120041