Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Placebo
Dexamethasone 1 mg
Dexamethasone 2 mg
Dexamethasone 3 mg
Dexamethasone 4 mg
Ropivacaine 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
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
Sites / Locations
- AZ Groeninge Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control group
Dex 1
Dex 2
Dex 3
Dex 4
Arm Description
Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls
Outcomes
Primary Outcome Measures
Duration of analgesia
Secondary Outcome Measures
Duration of motor block
Onset time of action of sensory block
Onset time of action of motor block
Equivalent morphine consumption in postanesthetic care unit
Equivalent morphine consumption on postoperative day 1
Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)
Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)
Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)
Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)
Rate of postoperative nausea and vomiting (PONV)
Presence of PONV (YES/NO)
Rate of pruritus
Presence of pruritus (YES/NO)
Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)
Glycemia in postanesthetic care unit (mmol/l)
Rate of infection
Presence of infection (YES/NO)
Rate of infection
Presence of infection (YES/NO)
Rate of paresthesia
Presence of paresthesia (YES/NO)
Rate of muscle weakness
Presence of muscle weakness (YES/NO)
Full Information
NCT ID
NCT02818491
First Posted
June 23, 2016
Last Updated
January 6, 2020
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT02818491
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls
Arm Title
Dex 1
Arm Type
Active Comparator
Arm Description
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls
Arm Title
Dex 2
Arm Type
Active Comparator
Arm Description
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls
Arm Title
Dex 3
Arm Type
Active Comparator
Arm Description
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls
Arm Title
Dex 4
Arm Type
Active Comparator
Arm Description
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline 0.9% in 2 mls
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 1 mg
Intervention Description
Dexamethasone 1 mg in 2 mls
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 2 mg
Intervention Description
Dexamethasone 2 mg in 2 mls
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 3 mg
Intervention Description
Dexamethasone 3 mg in 2 mls
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4 mg
Intervention Description
Dexamethasone 4 mg in 2 mls
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5%
Intervention Description
Ropivacaine 0.5% 20 mls
Primary Outcome Measure Information:
Title
Duration of analgesia
Time Frame
24hour
Secondary Outcome Measure Information:
Title
Duration of motor block
Time Frame
24hour
Title
Onset time of action of sensory block
Time Frame
1hour
Title
Onset time of action of motor block
Time Frame
1hour
Title
Equivalent morphine consumption in postanesthetic care unit
Time Frame
4hour
Title
Equivalent morphine consumption on postoperative day 1
Time Frame
24hour
Title
Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)
Time Frame
4hour
Title
Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)
Time Frame
4hour
Title
Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)
Time Frame
24hour
Title
Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)
Time Frame
24hour
Title
Rate of postoperative nausea and vomiting (PONV)
Description
Presence of PONV (YES/NO)
Time Frame
24hour
Title
Rate of pruritus
Description
Presence of pruritus (YES/NO)
Time Frame
24hour
Title
Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)
Time Frame
24hour
Title
Glycemia in postanesthetic care unit (mmol/l)
Time Frame
4hour
Title
Rate of infection
Description
Presence of infection (YES/NO)
Time Frame
24hour
Title
Rate of infection
Description
Presence of infection (YES/NO)
Time Frame
7 days
Title
Rate of paresthesia
Description
Presence of paresthesia (YES/NO)
Time Frame
7 days
Title
Rate of muscle weakness
Description
Presence of muscle weakness (YES/NO)
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matthias Matthias, MD
Organizational Affiliation
AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Groeninge Hospital
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block
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