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NCT Number: NCT01577940

Method Study: Bilateral TAP Block With 24 Hours Infusion

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.

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Key information

Conditions

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

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

HOC, anesthesiology, Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Infusion of ropivacaine

Procedure

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.

Infusion of Saline

Procedure

TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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)

  4. Lung function

    Time frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block

    Inspiratory and expiratory force

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2012
Registry last updated
May 4, 2012

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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