Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic

Pain, Postoperative Clinical Trial

Official title:

Dual TAP Block Characteristics - Evaluation of Local Anesthetic Distribution by MR Scanning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305603
• Other study ID #: BBH-USG-PNB-1
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: April 10, 2013
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Using Magnetic resonance (MR) scanning and ultrasonography the investigators wish to investigate, in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators compare the anatomical distribution of the local anesthetic injectate in the TAP when performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical TAP block and a Dual TAP block.

Description:

There has been much debate as to what extent the classical TAP block will anesthetize more than the frontal dermatomes (TH10-Th12/L1). Some cadaver studies have been performed with injection of dye in the classical TAP. However, it is still not clear whether a single injection of local anesthetic in the classical TAP block position will reach the more cephalad and medial intercostal TAP plexus (Th6-Th9). In this study the investigators use MR scanning and ultrasonography to investigate in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators compare the anatomical distribution of the local anesthetic injectate in the TAP when performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical TAP block and a Dual TAP block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy male

• 18 years old or more

• had no previous abdominal surgery

• no regular medication

• no coagulation disorders

• no claustrophobia

Exclusion Criteria:

• if the volunteer is not able to accept an uncomplicated administration of a classical (single) or dual TAP block

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
On both sides of the abdomen 30 ml of bupivacaine 2.5 mg/ml will be injected. This is a total of 60 ml of bupivacaine 2.5 mg/ml.

Procedure:
• Injection
Injection under ultrasound-guidance

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Copenhagen University Hospital	Copenhagen	Capital Region of Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of local anesthetic evaluated by MR scanning		30 minutes after administering the TAP blocks	No
Secondary	Spread of anesthetized frontal dermatomes		30 minutes after administering the TAP blocks	No