Thermal QST for Interscale Block Evaluation

Nerve Block Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271867
• Other study ID #: EC 9/25/113
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2014
• Last updated: October 20, 2014
• Start date: July 2009

Study information

• Verified date: October 2014
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Anesthetics, Local
• Nerve Block

Intervention

Procedure:
• Interscalene block
An ultrasound guided ISB was performed with injection aimed to block the C5-root

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of sensory block		24 hours after intervention	No
Secondary	Degree of sensory stimulus detection threshold variation from baseline values	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	No
Secondary	Block duration		24 hours after intervention	No
Secondary	Use of rescue medication		24 hours after intervention	No
Secondary	Presence of motor block		24 hours after intervention	No