A Study Investigating Properties of the Transversus Abdominis Plane Block
This study is currently recruiting participants.
Verified August 2012 by Hillerod Hospital, Denmark
Sponsor:
Hillerod Hospital, Denmark
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
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Purpose
In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers:
- Cutaneous analgesic distribution
- Muscular affection
- 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:
- Cutaneous analgesic distribution
- 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
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, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013