The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

Phase 4

Completed

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Procedure: TAP block placebo; Procedure: transversus abdominis plane block

• Registration Number: NCT01046071
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Study Start: 2010-03
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-17
• Last Update Posted: 2011-11-18

Recruitment & Eligibility

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

Inclusion Criteria

• Laparoscopic cholecystectomy
• ASA 1-3
• BMI 18-35
• Written consent

Exclusion Criteria

• Do not understand danish
• Drug allergy
• Pregnancy
• Alcohol or drug abuse
• Chronic pain with consumption of opioids
• Consumption of NSAID, COX2inhibitors or paracetamol within 24 hours before the investigation
• Infection at the needle site.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
block with saline	TAP block placebo	20 ml of isotonic saline bilateral
transversus abdominis plane block	transversus abdominis plane block	transversus abdominis plane block with ropivacaine

Primary Outcome Measures

Name	Time	Method
Pain during cough.	0,2,4,6,8,24 hours postoperative	Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,24 hours postoperative.

Secondary Outcome Measures

Name	Time	Method
Pain during rest	0,2,4,6,8,24 hours postoperative	Area under the curve (AUC)-pain during rest based on measurements at 0,2,4,6,8,24 hours postoperative.
Total opioid consumption	0-24 hours postoperative	Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative.
Postoperative nausea and vomiting	0,2,4,6,8,24 hours postoperative	Nausea scores (0-3) at 0,2,4,6,8,24 hours postoperative. The number of vomits 0-2, 2-4, 4-6, 6-8 and 8-24 hours postoperative
Sedation	0,2,4,6,8,24 hours postoperative	Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative

Trial Locations

Locations (1)

Glostrup University Hospital, Department of anesthesia; 🇩🇰 Glostrup, Denmark