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

NCT01760174 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-05-12

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

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.

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER
  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Nils F Bjerregaard, M.D. · Aalborg University Hospital

  • Bodil S Rasmussen, M.D. + PhD · Aalborg Sygehus

  • Lone Nikolajsen, M.D, PhD · Aarhus University Hospital

  • Thomas F Bendtsen, MD, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01760174 on ClinicalTrials.gov