Thermal QST for Interscale Block Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthetics, Local Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Levobupivacaine 0,5%

Levobupivacaine 0,5% 15 ml once

Group Type ACTIVE_COMPARATOR

Interscalene block

Intervention Type PROCEDURE

An ultrasound guided ISB was performed with injection aimed to block the C5-root

Levobupivacaine 0,5% with epinephrine

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

Group Type ACTIVE_COMPARATOR

Interscalene block

Intervention Type PROCEDURE

An ultrasound guided ISB was performed with injection aimed to block the C5-root

Ropivacaine 0,75%

Ropivacaine 0,75% 15 ml once

Group Type ACTIVE_COMPARATOR

Interscalene block

Intervention Type PROCEDURE

An ultrasound guided ISB was performed with injection aimed to block the C5-root

Interventions

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Interscalene block

An ultrasound guided ISB was performed with injection aimed to block the C5-root

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR