Thermal QST for Interscale Block Evaluation

October 20, 2014 updated by: Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levobupivacaine 0,5%
Levobupivacaine 0,5% 15 ml once
Procedure: Interscalene block
An ultrasound guided ISB was performed with injection aimed to block the C5-root
Active Comparator: Levobupivacaine 0,5% with epinephrine
Levobupivacaine 0,5% with 1/200000 epinephrine 15 ml once
Procedure: Interscalene block
An ultrasound guided ISB was performed with injection aimed to block the C5-root
Active Comparator: Ropivacaine 0,75%
Ropivacaine 0,75% 15 ml once
Procedure: Interscalene block
An ultrasound guided ISB was performed with injection aimed to block the C5-root

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of sensory block
Time Frame: 24 hours after intervention
24 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of sensory stimulus detection threshold variation from baseline values
Time Frame: 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)
24 hours after intervention
Block duration
Time Frame: 24 hours after intervention
24 hours after intervention
Use of rescue medication
Time Frame: 24 hours after intervention
24 hours after intervention
Presence of motor block
Time Frame: 24 hours after intervention
24 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 13, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • EC 9/25/113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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