Method Study: Bilateral TAP Block With 24 Hours Infusion

Postoperative Pain Clinical Trial

Official title:

Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577940
• Other study ID #: SM1-PLP-11
• Secondary ID: 2011-005118-13
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2011
• Last updated: May 3, 2012
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• age between 18 and 30 years

• written consent

• ASA 1

• BMI between 18 and 25

• males

Exclusion Criteria:

• unable to communicate in Danish

• relevant drug allergy

• alcohol or/and drug abuse

• daily intake of prescription pain medication the last 4 weeks

• pain medication in the last 48 hours

• previously operated abdominal

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Infusion of ropivacaine
TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.
• Infusion of saline
TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

Locations

Country	Name	City	State
Denmark	HOC, anesthesiology, Rigshospitalet	Copenhagen
Denmark	HovedOrtoCentret, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements	Extent of sensory block using pinprick and ice	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	No
Secondary	Heat pain detection threshold (abdomen)	Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	No
Secondary	Heat pain detection threshold (dominant forearm)	Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	No
Secondary	Long Thermal stimulation (abdomen)	Heating of the skin, 45 degrees Celsius 1 minute. The participant indicates pain scores on a Visuel Analog Scale from 0 (no pain) to 100 (worst imaginable)	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	Yes
Secondary	Lung function	Inspiratory and expiratory force	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	No