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Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block

NCT02818491 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-01-07

No results posted yet for this study

Summary

Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Duration of analgesia is between eight to twelve hours depending on the type of administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics for a perineural injection may prolong the duration of analgesia up to 24 hours. In a meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose, without neurological complications. The objective of this multicenter randomised controlled double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that purpose, investigators will include a total of 150 patients divided in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.

Conditions

  • Postoperative Pain

Interventions

DRUG

Placebo

Normal saline 0.9% in 2 mls

DRUG

Dexamethasone 1 mg

Dexamethasone 1 mg in 2 mls

DRUG

Dexamethasone 2 mg

Dexamethasone 2 mg in 2 mls

DRUG

Dexamethasone 3 mg

Dexamethasone 3 mg in 2 mls

DRUG

Dexamethasone 4 mg

Dexamethasone 4 mg in 2 mls

DRUG

Ropivacaine 0.5%

Ropivacaine 0.5% 20 mls

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Eric Albrecht, MD · Centre Hospitalier Universitaire Vaudois

  • Matthias Matthias, MD · AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-11-01
Completion
2018-11-01

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02818491 on ClinicalTrials.gov