Clinical trial NCT02818491: Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block
Official title: Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of analgesia
timeFrame: 24hour
Secondary outcomes:
measure: Duration of motor block
timeFrame: 24hour
measure: Onset time of action of sensory block
timeFrame: 1hour
measure: Onset time of action of motor block
timeFrame: 1hour
measure: Equivalent morphine consumption in postanesthetic care unit
timeFrame: 4hour
measure: Equivalent morphine consumption on postoperative day 1
timeFrame: 24hour
measure: Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)
timeFrame: 4hour
measure: Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)
timeFrame: 4hour
measure: Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)
timeFrame: 24hour
measure: Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)
timeFrame: 24hour
measure: Rate of postoperative nausea and vomiting (PONV)
timeFrame: 24hour
measure: Rate of pruritus
timeFrame: 24hour
measure: Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)
timeFrame: 24hour
measure: Glycemia in postanesthetic care unit (mmol/l)
timeFrame: 4hour
measure: Rate of infection
timeFrame: 24hour
measure: Rate of infection
timeFrame: 7 days
measure: Rate of paresthesia
timeFrame: 7 days
measure: Rate of muscle weakness
timeFrame: 7 days
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: AZ Groeninge Hospital
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Albrecht, MD
role: STUDY_DIRECTOR
affiliation: AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium
name: Matthias Matthias, MD
role: PRINCIPAL_INVESTIGATOR
References: