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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
History of Changes

January 8, 2010
November 17, 2011
March 2010
February 2011   (final data collection date for primary outcome measure)
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.
Pain severity [ Time Frame: 0,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01046071 on ClinicalTrials.gov Archive Site
  • 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
postoperative opioid consumption [ Time Frame: 0,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Laparoscopic Cholecystectomy
  • 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
  • Procedure: TAP block placebo
    UL-guided TAP block with 20 ml of saline bilaterally, single dose.
    Other Name: placebo block
  • Experimental: transversus abdominis plane block
    transversus abdominis plane block with ropivacaine
    Intervention: Procedure: transversus abdominis plane block
  • Placebo Comparator: block with saline
    20 ml of isotonic saline bilateral
    Intervention: Procedure: TAP block placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01046071
SM1-plp-09, 2009-017420-75
Yes
Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen
Glostrup University Hospital, Copenhagen
Not Provided
Principal Investigator: Pernille L Petersen, MD Copenhagen university hospital, Glostrup
Glostrup University Hospital, Copenhagen
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP