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

NCT ID: NCT02691442

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2016-04-30

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.

Conditions

Other Peripheral Nerve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine 0.75%

The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.75%

Intervention Type: DRUG

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

Levobupivacaine 0.5%

The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space

Group Type: ACTIVE_COMPARATOR

Levobupivacaine 0.5%

Intervention Type: DRUG

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

Levobupivacaine 0.5% + epinephrin

The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space

Group Type: ACTIVE_COMPARATOR

Levobupivacaine 0.5% + epinephrin 1/200000

Intervention Type: DRUG

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

Interventions

Ropivacaine 0.75%

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

Intervention Type: DRUG

Levobupivacaine 0.5%

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Naropin; Chirocaine; Chirocaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Tom Schepens, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luc Serieus, MD

Role: STUDY_CHAIR

University Hospital, Antwerp

References

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.

Reference Type: DERIVED

PMID: 29725795 (View on PubMed)

Other Identifiers

EC 10/45/315

Identifier Type: -

Identifier Source: org_study_id