Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

NCT02412657 | Completed Results DMC

• 1 other identifier: dexaISB
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  Defined as the time between the performance of the block and the first analgesic request

  48 hours after surgery

Secondary Outcomes (4)

• Pain Scores

  every 6 hours during the first 48 hours after surgery

• Residual Motor Block

  24 hours and 48 hours

• Sleep Disturbance

  24 hours and 48 hours

• Patients Overall Satisfaction

  48 hours

Study Arms (3)

Dexamethasone 10 mg intravenous

EXPERIMENTAL

Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block

Drug: Dexamethasone

Dexamethasone 4 mg intravenous

EXPERIMENTAL

Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block

Drug: Dexamethasone

Normal Saline 20 mL intravenous

PLACEBO COMPARATOR

Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block

Drug: Normal Saline

Interventions

Dexamethasone DRUG

After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v.

Also known as: decadron

Dexamethasone 10 mg intravenous; Dexamethasone 4 mg intravenous

Normal Saline DRUG

Normal Saline 20 mL intravenous

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
• ASA I-III
• Age 18-80 years old

You may not qualify if:

• Any contraindication to interscalene brachial plexus block anesthesia
• Interscalene brachial plexus block failure
• Known local anesthetics allergy
• Dexamethasone allergy or intolerance
• Any contraindication to acetaminophen
• Any contraindication to morphine or hydromorphone
• Brachial plexus neuropathies
• Chronic pain syndrome other than shoulder pain
• Routine use of opioid medication
• Routine use of systemic corticosteroid
• Pregnancy
• Weight below 50 kilograms
• Incapability to understand a numeric verbal pain scale
• Incapability to consent
• Patient refusal

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (3)

Hopital Pierre-Boucher

Longueuil, Quebec, J4M 2A5, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 4M5, Canada

Location

Hopital Hotel-Dieu de Sorel

Sorel-Tracy, Quebec, J3P 1N5, Canada

Location

Related Publications (1)

• Chalifoux F, Colin F, St-Pierre P, Godin N, Brulotte V. Low dose intravenous dexamethasone (4 mg and 10 mg) significantly prolongs the analgesic duration of single-shot interscalene block after arthroscopic shoulder surgery: a prospective randomized placebo-controlled study. Can J Anaesth. 2017 Mar;64(3):280-289. doi: 10.1007/s12630-016-0796-6. Epub 2017 Jan 3.

  PMID: 28050801 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Dexamethasone; Calcium Dobesilate; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Veronique Brulotte
• Organization: MaisonneuveRH

veronique.brulotte@umontreal.ca

(514)252-3400

Study Officials

• Veronique Brulotte, MD MSc FRCPC

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Dre Veronique Brulotte, MD, M.Sc, FRCPC, anesthesiologist

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 9, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 13, 2018
• Results First Posted: April 12, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (3)