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Completed

NCT Number: NCT01679392

A Study Investigating Properties of the Transversus Abdominis Plane Block

In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers:

1. Cutaneous analgesic distribution 2. Muscular affection 3. Reproducibility

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Key information

Conditions

Anesthesia, Local

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hillerød Hospital

Hillerød, 3400, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Capable
  • American society of anesthesiologists classification 1 or 2
  • Written informed consent

Exclusion criteria

  • Age below 18 years
  • American society of anesthesiologists classification above 2
  • Body weight below 50 kg
  • Body mass index > 35 kg/m2
  • Previous abdominal surgery
  • Acute or chronic pain
  • Use of pain medication less than 24 h prior to study start
  • Allergy to local anesthetics
  • Pregnancy
  • Breastfeeding

Treatment and study plan

Ropivacaine

Drug

Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)

Other names: Naropin

Primary outcomes

  1. Cutaneous analgesic distribution

    Time frame: 90 min

    Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration

Secondary outcomes

  1. Muscular affection of the transversus abdominis plane block

    Time frame: 90 min

    Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions

  2. Reproducibility of the transversus abdominis plane block

    Time frame: At least 2 days

    Reproducibility of the transversus abdominis plane block with respect to:

    • Cutaneous analgesic distribution
    • Abdominal wall muscle affection measured in the same individual separated by at least 2 days

Sponsors and collaborators

Lead sponsor

Hillerod Hospital, Denmark

Other

Registry information

Official study title

Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2012
Registry last updated
Mar 20, 2015

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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