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Completed

NCT Number: NCT01046071

The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Laparoscopic Cholecystectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glostrup University Hospital, Department of anesthesia

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transversus abdominis plane block

Procedure

UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.

Other names: Naropine, Postoperative pain, UL-guided nerve block

TAP block placebo

Procedure

UL-guided TAP block with 20 ml of saline bilaterally, single dose.

Other names: placebo block

Primary outcomes

  1. 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

  1. Pain during rest

    Time frame: 0,2,4,6,8,24 hours postoperative

    Area under the curve (AUC)-pain during rest based on measurements at 0,2,4,6,8,24 hours postoperative.

  2. Total opioid consumption

    Time frame: 0-24 hours postoperative

    Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative.

  3. Postoperative nausea and vomiting

    Time frame: 0,2,4,6,8,24 hours postoperative

    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

  4. Sedation

    Time frame: 0,2,4,6,8,24 hours postoperative

    Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2010
Registry last updated
Nov 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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