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A Study Investigating Properties of the Transversus Abdominis Plane Block

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679392
First Posted: September 6, 2012
Last Update Posted: March 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark
  Purpose

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

Condition Intervention
Anesthesia, Local Drug: Ropivacaine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Cutaneous analgesic distribution [ Time Frame: 90 min ]
    Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration


Secondary Outcome Measures:
  • 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

  • Reproducibility of the transversus abdominis plane block [ Time Frame: At least 2 days ]

    Reproducibility of the transversus abdominis plane block with respect to:

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


Enrollment: 16
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine
Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)
Drug: Ropivacaine
Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)
Other Name: Naropin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679392


Locations
Denmark
Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Investigators
Principal Investigator: Kion Bo Støving, MD Hillerod Hospital, Denmark
Study Director: Charlotte Rosenstock, MD Hillerod Hospital, Denmark
Study Director: Kai Lange, MD Hillerod Hospital, Denmark
  More Information

Responsible Party: Kai Henrik Wiborg Lange, Associate Professor, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01679392     History of Changes
Other Study ID Numbers: H-1-2011-030
2011-004719-22 ( EudraCT Number )
First Submitted: August 27, 2012
First Posted: September 6, 2012
Last Update Posted: March 20, 2015
Last Verified: March 2015

Keywords provided by Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark:
Transversus abdominis plane block
Ultrasound guided nerve block

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents