Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

NCT ID: NCT02412657

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-11-30

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexamethasone 10 mg intravenous

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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.

Dexamethasone 4 mg intravenous

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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.

Normal Saline 20 mL intravenous

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

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Interventions

Dexamethasone

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.

Intervention Type: DRUG

Normal Saline

Intervention Type: DRUG

Other Intervention Names

decadron

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Veronique Brulotte

Dre Veronique Brulotte, MD, M.Sc, FRCPC, anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronique Brulotte, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

Hopital Pierre-Boucher

Longueuil, Quebec, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Hopital Hotel-Dieu de Sorel

Sorel-Tracy, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28050801 (View on PubMed)

Other Identifiers

dexaISB

Identifier Type: -

Identifier Source: org_study_id