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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01760174

Enrollment

Registered

2013-01-04

Start date

2016-01-31

Completion date

2017-02-28

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Transversus abdominis plane catheter

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.

Interventions

DRUGRopivacaine 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.

DRUGBupivacain-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients scheduled for open gynecologic surgery * acceptance to participate

Exclusion criteria

* allergies to local analgetics * daily use of strong opioids

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026