Method Study: Bilateral TAP Block With 24 Hours Infusion

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01577940

Enrollment

Registered

2012-04-16

Start date

2011-01-31

Completion date

2012-05-31

Last updated

2012-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Transversus abdominis plane block, postoperative pain, Postoperative pain management

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.

Interventions

PROCEDUREInfusion 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.

PROCEDUREInfusion of saline

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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)
Lung function	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	Inspiratory and expiratory force

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026