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A Study Investigating Properties of the Transversus Abdominis Plane Block

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.
 
ClinicalTrials.gov Identifier: NCT01679392
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark

Brief Summary:

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 or disease Intervention/treatment Phase
Anesthesia, Local Drug: Ropivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


Secondary Outcome Measures :
  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:

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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Denmark
Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Investigators
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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

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Responsible Party: Kai Henrik Wiborg Lange, Associate Professor, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01679392    
Other Study ID Numbers: H-1-2011-030
2011-004719-22 ( EudraCT Number )
First Posted: September 6, 2012    Key Record Dates
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:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents