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Thermal QST for Interscale Block Evaluation

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ClinicalTrials.gov Identifier: NCT02271867
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, 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.

Condition or disease Intervention/treatment Phase
Anesthetics, Local Nerve Block Procedure: Interscalene block Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Thermal Quantitative Sensory Testing as a Method to Semi-quantitatively Assess the Neurosensory Effects of 3 Local Anesthetic Solutions in an Interscalene Block
Study Start Date : July 2009
Actual Primary Completion Date : August 2010

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




Primary Outcome Measures :
  1. Presence of sensory block [ Time Frame: 24 hours after intervention ]

Secondary Outcome Measures :
  1. 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)

  2. Block duration [ Time Frame: 24 hours after intervention ]
  3. Use of rescue medication [ Time Frame: 24 hours after intervention ]
  4. Presence of motor block [ Time Frame: 24 hours after intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271867


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02271867     History of Changes
Other Study ID Numbers: EC 9/25/113
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents