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Clinical Trials/NCT02271867
NCT02271867CompletedPhase 4

Thermal Quantitative Sensory Testing as a Method to Semi-quantitatively Assess the Neurosensory Effects of 3 Local Anesthetic Solutions in an Interscalene Block

University Hospital, Antwerp1 site in 1 country45 target enrollmentStarted: July 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Presence of sensory block

Study Overview

Brief Summary

Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible

Exclusion Criteria

  • •contraindications for ISB
  • •diabetes mellitus
  • •peripheral neuropathy
  • •patients receiving chronic analgesic therapy
  • •contraindications for NSAID
  • •patients with an initial QST with abnormal values

Arms & Interventions

Levobupivacaine 0,5%

Active Comparator

Levobupivacaine 0,5% 15 ml once

Intervention: Interscalene block (Procedure)

Levobupivacaine 0,5% with epinephrine

Active Comparator

Levobupivacaine 0,5% with 1/200000 epinephrine 15 ml once

Intervention: Interscalene block (Procedure)

Ropivacaine 0,75%

Active Comparator

Ropivacaine 0,75% 15 ml once

Intervention: Interscalene block (Procedure)

Outcomes

Primary Outcomes

Presence of sensory block

Time Frame: 24 hours after intervention

Secondary Outcomes

  • Block duration(24 hours after intervention)
  • Degree of sensory stimulus detection threshold variation from baseline values(24 hours after intervention)
  • Presence of motor block(24 hours after intervention)
  • Use of rescue medication(24 hours after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ethisch Comité UZ Antwerpen

Thermal Quantitative Sensory Testing as a method to semi-quantitatively assess the neurosensory effects of 3 local anesthetic solutions in an interscalene block

University Hospital, Antwerp

Study Sites (1)

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