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

October 26, 2016 updated by: Tom Schepens, MD, University Hospital, Antwerp

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
NaCl 0.9% 3ml perineural stellate ganglion injection
Drug: NaCl 0.9%
Inject 3ml of NaCl 0.9% into the stellate ganglion area
Active Comparator: Stellate ganglion block
Levobupivacaine 3ml perineural stellate ganglion injection
Drug: Levobupivacaine
Inject 3ml of levobupavacaine into the stellate ganglion area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia
Time Frame: 24 hours
The duration of analgesia assessed with quantitative sensory testing
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for rescue analgesia
Time Frame: 24 hours
The timing of the need for rescue analgesia as requested by the patient
24 hours
Duration of motor block
Time Frame: 24 hours
The duration of a motor block
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Luc Sermeus, MD, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/20/162
  • B300201111454 (Registry Identifier: FAGG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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