The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Procedure: transversus abdominis plane block; Procedure: TAP block placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Glostrup University Hospital, Department of anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transversus abdominis plane block; transversus abdominis plane block with ropivacaine	Procedure: transversus abdominis plane block; UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.; Other Names: Naropine; Postoperative pain; UL-guided nerve block
Placebo Comparator: block with saline; 20 ml of isotonic saline bilateral	Procedure: TAP block placebo; UL-guided TAP block with 20 ml of saline bilaterally, single dose.; Other Names: placebo block

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during rest	Area under the curve (AUC)-pain during rest based on measurements at 0,2,4,6,8,24 hours postoperative.	0,2,4,6,8,24 hours postoperative
Total opioid consumption	Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative.	0-24 hours postoperative
Postoperative nausea and vomiting	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	0,2,4,6,8,24 hours postoperative
Sedation	Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative	0,2,4,6,8,24 hours postoperative

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Pernille L Petersen, MD, Copenhagen University Hospital, Glostrup

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Transversus abdominis plane block, postoperative pain.
• Other Study ID Numbers: SM1-plp-09; 2009-017420-75 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No