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Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

Information source: Maisonneuve-Rosemont Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Dexamethasone (Drug); Normal Saline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Maisonneuve-Rosemont Hospital

Official(s) and/or principal investigator(s):
Veronique Brulotte, MD MSc FRCPC, Principal Investigator, Affiliation: Maisonneuve-Rosemont Hospital

Overall contact:
Véronique Brulotte, MD MSc FRCPC, Phone: 514-252-3400, Ext: 4558, Email: veronique.brulotte@umontreal.ca

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.

Clinical Details

Official title: Impact of Two Doses of Intravenous Dexamethasone on the Analgesic Duration of a Single-shot Interscalene Block With Ropivacaine for Shoulder Arthroscopy; a Prospective, Randomized, Placebo-controlled Study

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Duration of analgesia

Secondary outcome:

total opioid consumption (mg)

pain scores

residual motor block

sleep disturbance

patients overall satisfaction

Detailed description: 75 patients will be randomly assigned to three groups:

- D10: dexamethasone 10 mg I. V. diluted in normal saline 20cc, immediately after inter

scalene block

- D4: dexamethasone 4 mg I. V. diluted in normal saline 20cc, immediately after inter

scalene block

- C: control: Normal saline 20cc I. V., immediately after inter scalene block. These

patient will be recruited from 3 hospitals, with two surgeons performing the surgeries. All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0. 5% 20cc. In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached >3/10. They will note the time and day at which this outcome occurs.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Locations and Contacts

Véronique Brulotte, MD MSc FRCPC, Phone: 514-252-3400, Ext: 4558, Email: veronique.brulotte@umontreal.ca

Hopital Pierre-Boucher, Longueuil, Quebec J4M 2A5, Canada; Recruiting
St-Pierre Patrick, Phone: 450-468-8111

Maisonneuve-Rosemont Hospital, Montreal, Quebec H1T 4M5, Canada; Recruiting
Véronique Brulotte, MD MSc FRCPC, Phone: 514-252-3400, Ext: 4558, Email: veronique.brulotte@umontreal.ca
Véronique Brulotte, MD MSc FRCPC, Principal Investigator

Hopital Hotel-Dieu de Sorel, Sorel, Quebec J3P 1N5, Canada; Recruiting
Ahmed-Yahia Mostefai, Phone: 514-746-6000

Additional Information

Starting date: September 2014
Last updated: April 8, 2015

Page last updated: August 23, 2015

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