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

A

Antwerp University Hospital (UZA)

Status and phase

Completed
Phase 4

Conditions

Other Peripheral Nerve Disease

Treatments

Drug: Levobupivacaine 0.5%
Drug: Levobupivacaine 0.5% + epinephrin 1/200000
Drug: Ropivacaine 0.75%

Study type

Interventional

Funder types

Other

Identifiers

NCT02691442
EC 10/45/315

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 3 patient groups

Ropivacaine 0.75%
Active Comparator group
Description:
The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space
Treatment:
Drug: Ropivacaine 0.75%
Levobupivacaine 0.5%
Active Comparator group
Description:
The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space
Treatment:
Drug: Levobupivacaine 0.5%
Levobupivacaine 0.5% + epinephrin
Active Comparator group
Description:
The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space
Treatment:
Drug: Levobupivacaine 0.5% + epinephrin 1/200000

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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