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Clinical Trials/NCT01577940
NCT01577940CompletedPhase 4

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

Glostrup University Hospital, Copenhagen4 sites in 1 country8 target enrollmentStarted: January 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
8
Locations
4
Primary Endpoint
Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •age between 18 and 30 years
  • •written consent
  • •BMI between 18 and 25

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

Outcomes

Primary Outcomes

Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements

Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block

Extent of sensory block using pinprick and ice

Secondary Outcomes

  • Heat pain detection threshold (abdomen)(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)
  • Heat pain detection threshold (dominant forearm)(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)
  • Long Thermal stimulation (abdomen)(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)
  • Lung function(-15 min., 1, 4, 8, 12 and 24 hours following TAP block)

Investigators

Sponsor
Glostrup University Hospital, Copenhagen
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pernille Lykke Petersen

Principal investigator

Glostrup University Hospital, Copenhagen

Study Sites (4)

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