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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02691442

Enrollment

Registered

2016-02-25

Start date

2010-12-31

Completion date

2016-04-30

Last updated

2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Peripheral Nerve Disease

Keywords

Peripheral nerve block

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.

Interventions

DRUGRopivacaine 0.75%

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

DRUGLevobupivacaine 0.5%

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

DRUGLevobupivacaine 0.5% + epinephrin 1/200000

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	24 hours after intervention	The difference in threshold of cold and heat pain and sensation measured with quantitative sensory testing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026