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Completed

NCT Number: NCT02691442

Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery

Several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. The most widely used method for sensory function evaluation is though means of a pinprick test. The investigators want to use the novel method of Quantitative Sensory Testing to better evaluate the anesthetic activity. This method used hot and cold sensation to assess small nerve fiber function. The investigators will assess the duration of action of different drugs when used in an inter scalene nerve block in patients scheduled for shoulder surgery.

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Key information

Conditions

Other Peripheral Nerve Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This study aims to compare the length of the analgesic effect of different local anesthesic solutions, used in an interscalene nerve block. This will be objectified by measuring the changes in small nerve functioning, using quantative sensory testing. Based on the results of a previous study, the investigators reduce the dose of the administered local anesthetic, expecting a similar length of action using these smaller doses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesia class I or II
  • Scheduled for shoulder surgery

Exclusion criteria

  • Mental retardation
  • Allergy for local anesthetics
  • NSAID intolerance or contraindicated
  • Diabetes mellitus
  • Chronic use of pain killers

Treatment and study plan

Ropivacaine 0.75%

Drug

The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block

Other names: Naropin

Levobupivacaine 0.5%

Drug

The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block

Other names: Chirocaine

Levobupivacaine 0.5% + epinephrin 1/200000

Drug

The investigators adminster 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in an ultrasound-guided inter scalene nerve block

Other names: Chirocaine

Primary outcomes

  1. Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing

    Time frame: 24 hours after intervention

    Length of difference in cold and heat pain and sensation measured with quantitative sensory testing

Secondary outcomes

  1. Need for rescue drugs, as requested by the patient after surgery

    Time frame: 24 hours after intervention

  2. Motor activity block, longitudinally recorded inability to move the blocked limb

    Time frame: 24 hours after intervention

  3. Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing

    Time frame: 24 hours after intervention

    The difference in threshold of cold and heat pain and sensation measured with quantitative sensory testing

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Comparison of the Analgesic Effect of the Local Anesthetics Ropicacaine, Levobupivacaine, and Levobupivacaine + Epinephrin Via Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopy Under General Anesthesia

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Feb 25, 2016
Registry last updated
Aug 15, 2016

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.