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Clinical Trials/NCT01046071
NCT01046071
Completed
Phase 4

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

Glostrup University Hospital, Copenhagen1 site in 1 country80 target enrollmentMarch 2010
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ConditionsLaparoscopic Cholecystectomy

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Laparoscopic Cholecystectomy
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
80
Locations
1
Primary Endpoint
Pain during cough.
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
February 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Glostrup University Hospital, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Pernille Lykke Petersen

MD

Glostrup University Hospital, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • •Laparoscopic cholecystectomy
  • •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.

Outcomes

Primary Outcomes

Pain during cough.

Time Frame: 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 Outcomes

  • Pain during rest(0,2,4,6,8,24 hours postoperative)
  • Total opioid consumption(0-24 hours postoperative)
  • Postoperative nausea and vomiting(0,2,4,6,8,24 hours postoperative)
  • Sedation(0,2,4,6,8,24 hours postoperative)

Study Sites (1)

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