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

Other Peripheral Nerve Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691442
• Other study ID #: EC 10/45/315
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2016
• Last updated: August 11, 2016
• Start date: December 2010
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nervous System Diseases
• Other Peripheral Nerve Disease
• Peripheral Nervous System Diseases

Intervention

Drug:
• Ropivacaine 0.75%
The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block
• Levobupivacaine 0.5%
The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Need for rescue drugs, as requested by the patient after surgery		24 hours after intervention	No
Secondary	Motor activity block, longitudinally recorded inability to move the blocked limb		24 hours after intervention	No
Secondary	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	No