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

This study is not yet open for participant recruitment.
Verified January 2013 by Aalborg Universityhospital
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Nils Bjerregaard, Aalborg Hospital
ClinicalTrials.gov Identifier:
NCT01760174
First received: July 26, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Pain, Postoperative
 Drug: Ropivacaine bolus in transversus abdominis plane catheter
Drug: Bupivacain-infusion in epidural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Potassium
U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Pain-score on numerical rating scale [ Time Frame: 4 hours after first bolus in tranversus abdominis catheters ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Administration of opioids [ Time Frame: The first 24 hours after surgery. ] [ Designated as safety issue: No ]
  • Pain-score on numerical rating scale [ Time Frame: 8 hours after first bolus in tranversus abdominis catheters ] [ Designated as safety issue: No ]
  • Pain-score on numerical rating scale [ Time Frame: 24 hours after first bolus in tranversus abdominis catheters ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Thermoanalgesia at dermatome-level th10-th12 [ Time Frame: 4 hours after first bolus in TAP-catherter ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for open gynecologic surgery
  • acceptance to participate

Exclusion Criteria:

  • allergies to local analgetics
  • daily use of strong opioids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760174

Contacts
Contact: Nils F Bjerregaard, M.D. 0045 22 86 06 49 niheb@rn.dk

Locations
Denmark
Aalborg Hospital Not yet recruiting
Aalborg, Region Nord, Denmark, 9000
Contact: Nils F Bjerregaard, MD     0045 22 86 06 49     niheb@rn.dk    
Principal Investigator: Nils F Bjerregaard, M.D.            
Sponsors and Collaborators
Aalborg Universityhospital
Aarhus University Hospital
Investigators
Principal Investigator: Nils F Bjerregaard, M.D. Aalborg Universityhospital
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
  More Information

No publications provided

Responsible Party: Nils Bjerregaard, Consultant Anesthetist, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT01760174     History of Changes
Other Study ID Numbers: N-20120041
Study First Received: July 26, 2012
Last Updated: January 2, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aalborg Universityhospital:
Transversus abdominis plane catheter

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Ropivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013