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Clinical Trials/NCT02879916
NCT02879916
Completed
Phase 4

Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia

University Hospital, Antwerp0 sites30 target enrollmentOctober 2011
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ConditionsAnesthesia, Regional
InterventionsNaCl 0.9%Levobupivacaine
DrugsLevobupivacaineNaCl 0.9%

Overview

Phase
Phase 4
Intervention
NaCl 0.9%
Conditions
Anesthesia, Regional
Sponsor
University Hospital, Antwerp
Enrollment
30
Primary Endpoint
Duration of analgesia
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tom Schepens, MD

research assistant

University Hospital, Antwerp

Eligibility Criteria

Inclusion Criteria

  • •ASA class 1 to 3
  • •Need for shoulder surgery

Exclusion Criteria

  • •Mental retardation
  • •allergy for local anesthetics
  • •a medical reason as a contra-indication for NSAID use
  • •Diabetes mellitus
  • •peripheral neuropathy
  • •chronic analgetic use
  • •chronic pain patients

Arms & Interventions

Placebo

NaCl 0.9% 3ml perineural stellate ganglion injection

Intervention: NaCl 0.9%

Stellate ganglion block

Levobupivacaine 3ml perineural stellate ganglion injection

Intervention: Levobupivacaine

Outcomes

Primary Outcomes

Duration of analgesia

Time Frame: 24 hours

The duration of analgesia assessed with quantitative sensory testing

Secondary Outcomes

  • Need for rescue analgesia(24 hours)
  • Duration of motor block(24 hours)

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