Overview

This trial has been completed.

Condition anesthesia, regional
Treatments levobupivacaine, nacl 0.9%
Phase phase 4
Sponsor University Hospital, Antwerp
Start date October 2011
End date December 2013
Trial size 30 participants
Trial identifier NCT02879916, 11/20/162, B300201111454

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
NaCl 0.9% 3ml perineural stellate ganglion injection
nacl 0.9%
Inject 3ml of NaCl 0.9% into the stellate ganglion area
(Active Comparator)
Levobupivacaine 3ml perineural stellate ganglion injection
levobupivacaine
Inject 3ml of levobupavacaine into the stellate ganglion area

Primary Outcomes

Measure
Duration of analgesia
time frame: 24 hours

Secondary Outcomes

Measure
Need for rescue analgesia
time frame: 24 hours
Duration of motor block
time frame: 24 hours

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official 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
Principal investigator Luc Sermeus, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospital, Antwerp.