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

Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine 0.5%; Drug: Dexamethasone 1 mg; Drug: Dexamethasone 2 mg; Drug: Dexamethasone 3 mg; Drug: Dexamethasone 4 mg

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium, 8500
    • AZ Groeninge Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls	Drug: Placebo; Normal saline 0.9% in 2 mls; Drug: Ropivacaine 0.5%; Ropivacaine 0.5% 20 mls
Active Comparator: Dex 1; Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls	Drug: Ropivacaine 0.5%; Ropivacaine 0.5% 20 mls; Drug: Dexamethasone 1 mg; Dexamethasone 1 mg in 2 mls
Active Comparator: Dex 2; Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls	Drug: Ropivacaine 0.5%; Ropivacaine 0.5% 20 mls; Drug: Dexamethasone 2 mg; Dexamethasone 2 mg in 2 mls
Active Comparator: Dex 3; Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls	Drug: Ropivacaine 0.5%; Ropivacaine 0.5% 20 mls; Drug: Dexamethasone 3 mg; Dexamethasone 3 mg in 2 mls
Active Comparator: Dex 4; Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls	Drug: Ropivacaine 0.5%; Ropivacaine 0.5% 20 mls; Drug: Dexamethasone 4 mg; Dexamethasone 4 mg in 2 mls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of analgesia	24hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)		4hour
Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)		4hour
Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)		24hour
Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)		24hour
Rate of postoperative nausea and vomiting (PONV)	Presence of PONV (YES/NO)	24hour
Rate of pruritus	Presence of pruritus (YES/NO)	24hour
Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)		24hour
Glycemia in postanesthetic care unit (mmol/l)		4hour
Rate of infection	Presence of infection (YES/NO)	24hour
Rate of infection	Presence of infection (YES/NO)	7 days
Rate of paresthesia	Presence of paresthesia (YES/NO)	7 days
Rate of muscle weakness	Presence of muscle weakness (YES/NO)	7 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Study Director: Eric Albrecht, MD, Centre Hospitalier Universitaire Vaudois; Principal Investigator: Matthias Matthias, MD, AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Ropivacaine
• Other Study ID Numbers: CER 217/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No