The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046071
• Other study ID #: SM1-plp-09
• Secondary ID: 2009-017420-75
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2010
• Last updated: November 17, 2011
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• transversus abdominis plane block
UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.
• TAP block placebo
UL-guided TAP block with 20 ml of saline bilaterally, single dose.

Locations

Country	Name	City	State
Denmark	Glostrup University Hospital, Department of anesthesia	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Total opioid consumption	Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative.	0-24 hours postoperative	No
Secondary	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	No
Secondary	Sedation	Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative	0,2,4,6,8,24 hours postoperative	No