A Study Investigating Properties of the Transversus Abdominis Plane Block

March 19, 2015 updated by: Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hillerød, Denmark, 3400
        • Hillerød Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous analgesic distribution
Time Frame: 90 min
Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration
90 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 min
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
At least 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2011-030
  • 2011-004719-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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