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

NCT02818491 | Completed Phase 4

• 1 other identifier: CER 217/15
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  24hour

Secondary Outcomes (17)

• Duration of motor block

  24hour

• Onset time of action of sensory block

  1hour

• Onset time of action of motor block

  1hour

• Equivalent morphine consumption in postanesthetic care unit

  4hour

• Equivalent morphine consumption on postoperative day 1

  24hour

Study Arms (5)

Control group

PLACEBO COMPARATOR

Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls

Drug: Placebo; Drug: Ropivacaine 0.5%

Dex 1

ACTIVE COMPARATOR

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls

Drug: Dexamethasone 1 mg; Drug: Ropivacaine 0.5%

Dex 2

ACTIVE COMPARATOR

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls

Drug: Dexamethasone 2 mg; Drug: Ropivacaine 0.5%

Dex 3

ACTIVE COMPARATOR

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls

Drug: Dexamethasone 3 mg; Drug: Ropivacaine 0.5%

Dex 4

ACTIVE COMPARATOR

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls

Drug: Dexamethasone 4 mg; Drug: Ropivacaine 0.5%

Interventions

Placebo DRUG

Normal saline 0.9% in 2 mls

Control group

Dexamethasone 1 mg DRUG

Dexamethasone 1 mg in 2 mls

Dex 1

Dexamethasone 2 mg DRUG

Dexamethasone 2 mg in 2 mls

Dex 2

Dexamethasone 3 mg DRUG

Dexamethasone 3 mg in 2 mls

Dex 3

Dexamethasone 4 mg DRUG

Dexamethasone 4 mg in 2 mls

Dex 4

Ropivacaine 0.5% DRUG

Ropivacaine 0.5% 20 mls

Control group; Dex 1; Dex 2; Dex 3; Dex 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for elective shoulder arthroscopy
• duration of surgery less than 4 hours

You may not qualify if:

• allergy to local anaesthetics
• history of neck surgery
• history of neck radiotherapy
• severe respiratory disease
• diabetic patient
• chronic pain condition
• pregnancy
• patient suffering from cancer
• patient with addicted disease

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

AZ Groeninge Hospital

Kortrijk, 8500, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Eric Albrecht, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY DIRECTOR

• Matthias Matthias, MD

  AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD MD, Program director of regional anaesthesia

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 29, 2016
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

BE (1)