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

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

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.

Study Overview

• Status: Completed
• Conditions: Other Peripheral Nerve Disease
• Intervention / Treatment: Drug: Ropivacaine 0.75%; Drug: Levobupivacaine 0.5%; Drug: Levobupivacaine 0.5% + epinephrin 1/200000

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine 0.75%; The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space	Drug: Ropivacaine 0.75%; The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block; Other Names: Naropin
Active Comparator: Levobupivacaine 0.5%; The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space	Drug: Levobupivacaine 0.5%; The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block; Other Names: Chirocaine
Active Comparator: Levobupivacaine 0.5% + epinephrin; The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space	Drug: Levobupivacaine 0.5% + epinephrin 1/200000; The investigators adminster 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in an ultrasound-guided inter scalene nerve block; Other Names: Chirocaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Study Chair: Luc Serieus, MD, University Hospital, Antwerp

Publications and helpful links

General Publications

• Sermeus LA, Schepens T, Hans GH, Morrison SG, Wouters K, Breebaart MB, Smitz CJ, Vercauteren MP. A low dose of three local anesthetic solutions for interscalene blockade tested by thermal quantitative sensory testing: a randomized controlled trial. J Clin Monit Comput. 2019 Apr;33(2):307-316. doi: 10.1007/s10877-018-0150-3. Epub 2018 May 3.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 21, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Peripheral nerve block
• Additional Relevant MeSH Terms: Neuromuscular Diseases; Peripheral Nervous System Diseases; Nervous System Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Levobupivacaine; Epinephrine
• Other Study ID Numbers: EC 10/45/315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO