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

Anesthesia, Regional Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879916
• Other study ID #: 11/20/162
• Secondary ID: B300201111454
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2016
• Last updated: October 26, 2016
• Start date: October 2011
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Regional

Intervention

Drug:
• Levobupivacaine
Inject 3ml of levobupavacaine into the stellate ganglion area
• NaCl 0.9%
Inject 3ml of NaCl 0.9% into the stellate ganglion area

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of analgesia	The duration of analgesia assessed with quantitative sensory testing	24 hours	No
Secondary	Need for rescue analgesia	The timing of the need for rescue analgesia as requested by the patient	24 hours	No
Secondary	Duration of motor block	The duration of a motor block	24 hours	No