Method Study: Bilateral TAP Block With 24 Hours Infusion

Overview

The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.

Full Title of Study: “Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2012

Interventions

  • Procedure: Infusion of ropivacaine
    • TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.
  • Procedure: Infusion of saline
    • TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

Arms, Groups and Cohorts

  • Experimental: Infusion of local anesthetic
    • TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.
  • Placebo Comparator: Infusion of saline
    • TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.

Clinical Trial Outcome Measures

Primary Measures

  • Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
    • Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
    • Extent of sensory block using pinprick and ice

Secondary Measures

  • Heat pain detection threshold (abdomen)
    • Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
    • Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
  • Heat pain detection threshold (dominant forearm)
    • Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
    • Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
  • Long Thermal stimulation (abdomen)
    • Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
    • Heating of the skin, 45 degrees Celsius 1 minute. The participant indicates pain scores on a Visuel Analog Scale from 0 (no pain) to 100 (worst imaginable)
  • Lung function
    • Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
    • Inspiratory and expiratory force

Participating in This Clinical Trial

Inclusion Criteria

  • age between 18 and 30 years – written consent – ASA 1 – BMI between 18 and 25 – males Exclusion Criteria:

  • unable to communicate in Danish – relevant drug allergy – alcohol or/and drug abuse – daily intake of prescription pain medication the last 4 weeks – pain medication in the last 48 hours – previously operated abdominal

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Glostrup University Hospital, Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pernille Lykke Petersen, Principal investigator – Glostrup University Hospital, Copenhagen
  • Overall Official(s)
    • Pernille L Petersen, MD, Principal Investigator, HOC, anesthesiology, Rigshospitalet, Copenhagen

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