Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

Not Applicable

Terminated

• Conditions: Robotic Assisted Laparoscopic Surgery; Bilateral Dual Transversus Abdominis Plane Block; Pain Treatment
• Interventions: Drug: Isotonic potassium chloride; Drug: Ropivacaine

• Registration Number: NCT01760161
• Lead Sponsor: Aalborg University Hospital

Brief Summary

To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

Detailed Description

After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.

The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.

Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.

The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Study Timeline

• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-04
• Study Start: 2014-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12
• Primary Completion: 2015-12
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients scheduled for robotic assisted laparoscopis 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
Isotonic potassium chloride	Isotonic potassium chloride	Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
Ropivacain	Ropivacaine	Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block

Primary Outcome Measures

Name	Time	Method
Pain-score on numerical rating scale	4 hours after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aalborg Hospital; 🇩🇰 Aalborg, Region Nord, Denmark