Method Study: Bilateral TAP Block With 24 Hours Infusion

• Sponsor: Glostrup University Hospital, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01577940
• Collaborator: (none)
• Enrollment: 8
• Locations: 2
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Infusion of ropivacaine; Procedure: Infusion of saline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Infusion of local anesthetic TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.	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.
Placebo Comparator: Infusion of saline TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.	Procedure: Infusion of saline; TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

Outcome Measures

Primary Outcome Measures

1. Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements [-15 min., 1, 4, 8, 12 and 24 hours following TAP block]

   Extent of sensory block using pinprick and ice

Secondary Outcome Measures

1. Heat pain detection threshold (abdomen) [-15 min., 1, 4, 8, 12 and 24 hours following TAP block]

   Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.

2. Heat pain detection threshold (dominant forearm) [-15 min., 1, 4, 8, 12 and 24 hours following TAP block]

   Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.

3. Long Thermal stimulation (abdomen) [-15 min., 1, 4, 8, 12 and 24 hours following TAP block]

   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)

4. Lung function [-15 min., 1, 4, 8, 12 and 24 hours following TAP block]

   Inspiratory and expiratory force

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HOC, anesthesiology, Rigshospitalet	Copenhagen		Denmark	2100
2	HovedOrtoCentret, Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Glostrup University Hospital, Copenhagen

Investigators

• Principal Investigator: Pernille L Petersen, MD, HOC, anesthesiology, Rigshospitalet, Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pernille Lykke Petersen, Principal investigator, Glostrup University Hospital, Copenhagen
• ClinicalTrials.gov Identifier: NCT01577940
• Other Study ID Numbers: SM1-PLP-11; 2011-005118-13
• First Posted: Apr 16, 2012
• Last Update Posted: May 4, 2012
• Last Verified: May 1, 2012

• Keywords provided by Pernille Lykke Petersen, Principal investigator, Glostrup University Hospital, Copenhagen: Transversus abdominis plane block; postoperative pain; Postoperative pain management
• Additional relevant MeSH terms: Pain, Postoperative; Ropivacaine

Study Results

No Results Posted as of May 4, 2012