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

Phase 4

Completed

• Conditions: Other Peripheral Nerve Disease
• Interventions: Drug: Ropivacaine 0.75%; Drug: Levobupivacaine 0.5% + epinephrin 1/200000; Drug: Levobupivacaine 0.5%

• Registration Number: NCT02691442
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2015-12
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-21
• Study First Posted: 2016-02-25
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-11
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine 0.75%	Ropivacaine 0.75%	The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space
Levobupivacaine 0.5% + epinephrin	Levobupivacaine 0.5% + epinephrin 1/200000	The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space
Levobupivacaine 0.5%	Levobupivacaine 0.5%	The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space

Primary Outcome Measures

Name	Time	Method
Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing	24 hours after intervention	Length of difference in cold and heat pain and sensation measured with quantitative sensory testing

Secondary Outcome Measures

Name	Time	Method
Motor activity block, longitudinally recorded inability to move the blocked limb	24 hours after intervention
Need for rescue drugs, as requested by the patient after surgery	24 hours after intervention
Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing	24 hours after intervention	The difference in threshold of cold and heat pain and sensation measured with quantitative sensory testing