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

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ClinicalTrials.gov Identifier: NCT02691442
Recruitment Status : Completed
First Posted : February 25, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Tom Schepens, MD, 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.

Condition or disease Intervention/treatment Phase
Other Peripheral Nerve Disease Drug: Ropivacaine 0.75% Drug: Levobupivacaine 0.5% Drug: Levobupivacaine 0.5% + epinephrin 1/200000 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016


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 Name: 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 Name: 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 Name: Chirocaine




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691442


Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Study Chair: Luc Serieus, MD University Hospital, Antwerp

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tom Schepens, MD, MD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02691442     History of Changes
Other Study ID Numbers: EC 10/45/315
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tom Schepens, MD, University Hospital, Antwerp:
Peripheral nerve block
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Epinephrine
Racepinephrine
Anesthetics
Ropivacaine
Levobupivacaine
Anesthetics, Local
Epinephryl borate
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents