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A Study Investigating Properties of the Transversus Abdominis Plane Block

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hillerod Hospital, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01679392
First received: August 27, 2012
Last updated: September 5, 2012
Last verified: August 2012
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Cutaneous analgesic distribution [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 16
Study Start Date: August 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679392

Contacts
Contact: Kion Bo Støving, MD +4531141627 kstoeving@gmail.com
Contact: Kai Lange, MD +4531909730 klangedk@gmail.com

Locations
Denmark
Hillerød Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Kion Bo Støving, MD    +4531141627    kstoeving@gmail.com   
Principal Investigator: Kion Bo Støving, MD         
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

No publications provided

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
Study First Received: August 27, 2012
Last Updated: September 5, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hillerod Hospital, Denmark:
Transversus abdominis plane block
Ultrasound guided nerve block

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

ClinicalTrials.gov processed this record on November 20, 2014