The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01046071
First received: January 8, 2010
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Laparoscopic Cholecystectomy
Procedure: transversus abdominis plane block
Procedure: TAP block placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Pain during cough. [ Time Frame: 0,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,24 hours postoperative.


Secondary Outcome Measures:
  • Pain during rest [ Time Frame: 0,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    Area under the curve (AUC)-pain during rest based on measurements at 0,2,4,6,8,24 hours postoperative.

  • Total opioid consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
    Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative.

  • Postoperative nausea and vomiting [ Time Frame: 0,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative


Enrollment: 80
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: placebo block

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046071

Locations
Denmark
Glostrup University Hospital, Department of anesthesia
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Pernille L Petersen, MD Copenhagen university hospital, Glostrup
  More Information

No publications provided

Responsible Party: Pernille Lykke Petersen, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01046071     History of Changes
Other Study ID Numbers: SM1-plp-09, 2009-017420-75
Study First Received: January 8, 2010
Last Updated: November 17, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Glostrup University Hospital, Copenhagen:
Transversus abdominis plane block, postoperative pain.

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014