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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818491
• Other study ID #: CER 217/15
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Placebo
Normal saline 0.9% in 2 mls
• Dexamethasone 1 mg
Dexamethasone 1 mg in 2 mls
• Dexamethasone 2 mg
Dexamethasone 2 mg in 2 mls
• Dexamethasone 3 mg
Dexamethasone 3 mg in 2 mls
• Dexamethasone 4 mg
Dexamethasone 4 mg in 2 mls
• Ropivacaine 0.5%
Ropivacaine 0.5% 20 mls

Locations

Country	Name	City	State
Belgium	AZ Groeninge Hospital	Kortrijk

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of analgesia		24hour
Secondary	Duration of motor block		24hour
Secondary	Onset time of action of sensory block		1hour
Secondary	Onset time of action of motor block		1hour
Secondary	Equivalent morphine consumption in postanesthetic care unit		4hour
Secondary	Equivalent morphine consumption on postoperative day 1		24hour
Secondary	Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)		4hour
Secondary	Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)		4hour
Secondary	Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)		24hour
Secondary	Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)		24hour
Secondary	Rate of postoperative nausea and vomiting (PONV)	Presence of PONV (YES/NO)	24hour
Secondary	Rate of pruritus	Presence of pruritus (YES/NO)	24hour
Secondary	Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)		24hour
Secondary	Glycemia in postanesthetic care unit (mmol/l)		4hour
Secondary	Rate of infection	Presence of infection (YES/NO)	24hour
Secondary	Rate of infection	Presence of infection (YES/NO)	7 days
Secondary	Rate of paresthesia	Presence of paresthesia (YES/NO)	7 days
Secondary	Rate of muscle weakness	Presence of muscle weakness (YES/NO)	7 days