Thermal QST for Interscale Block Evaluation

Phase 4

Completed

• Conditions: Nerve Block; Anesthetics, Local
• Interventions: Procedure: Interscalene block

• Registration Number: NCT02271867
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-08
• Status Verified: 2014-10
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-20
• Last Update Submitted: 2014-10-20
• Study First Posted: 2014-10-22
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine 0,5%	Interscalene block	Levobupivacaine 0,5% 15 ml once
Ropivacaine 0,75%	Interscalene block	Ropivacaine 0,75% 15 ml once
Levobupivacaine 0,5% with epinephrine	Interscalene block	Levobupivacaine 0,5% with 1/200000 epinephrine 15 ml once

Primary Outcome Measures

Name	Time	Method
Presence of sensory block	24 hours after intervention

Secondary Outcome Measures

Name	Time	Method
Degree of sensory stimulus detection threshold variation from baseline values	24 hours after intervention	The higher the difference in detection threshold variation, the more intense the block. Measured as % change, where 100% change means no sensation on maximal QST stimulus (0°C for cold sensation and 50°C for warm sensation)
Presence of motor block	24 hours after intervention
Block duration	24 hours after intervention
Use of rescue medication	24 hours after intervention

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium