Method Study: Bilateral TAP Block With 24 Hours Infusion

Glostrup University Hospital, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Procedure: Infusion of saline; Procedure: Infusion of ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01577940

SM1-PLP-11

2011-005118-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Infusion of local anesthetic

Experimental group

Description:

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.

Treatment:

Procedure: Infusion of ropivacaine

Infusion of saline

Placebo Comparator group

Description:

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.

Treatment:

Procedure: Infusion of saline