A Study Investigating Properties of the Transversus Abdominis Plane Block

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679392
• Other study ID #: H-1-2011-030
• Secondary ID: 2011-004719-22
• Status: Completed
• Phase: N/A
• First received: August 27, 2012
• Last updated: March 19, 2015
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2015
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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

Locations

Country	Name	City	State
Denmark	Hillerød Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous analgesic distribution	Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration	90 min	No
Secondary	Muscular affection of the transversus abdominis plane block	Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions	90 min	No
Secondary	Reproducibility of the transversus abdominis plane block	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	At least 2 days	No