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Completed

NCT Number: NCT02271867

Thermal QST for Interscale Block Evaluation

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interscalene block

Procedure

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

Primary outcomes

  1. Presence of sensory block

    Time frame: 24 hours after intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Oct 22, 2014
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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