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Completed

NCT Number: NCT02879916

Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery

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.

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Key information

Conditions

Anesthesia, Regional

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

Inject 3ml of levobupavacaine into the stellate ganglion area

NaCl 0.9%

Drug

Inject 3ml of NaCl 0.9% into the stellate ganglion area

Primary outcomes

  1. Duration of analgesia

    Time frame: 24 hours

    The duration of analgesia assessed with quantitative sensory testing

Secondary outcomes

  1. Need for rescue analgesia

    Time frame: 24 hours

    The timing of the need for rescue analgesia as requested by the patient

  2. Duration of motor block

    Time frame: 24 hours

    The duration of a motor block

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Aug 26, 2016
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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