Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Normal Saline; Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Longueuil, Quebec, Canada, J4M 2A5
      • Hopital Pierre-Boucher
    • Montreal, Quebec, Canada, H1T 4M5
      • Maisonneuve-Rosemont Hospital
    • Sorel, Quebec, Canada, J3P 1N5
      • Hopital Hotel-Dieu de Sorel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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.; Other Names: decadron
Experimental: 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	Drug: 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.; Other Names: decadron
Placebo Comparator: Normal Saline 20 mL intravenous; Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block	Drug: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Analgesia	Defined as the time between the performance of the block and the first analgesic request	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)	every 6 hours during the first 48 hours after surgery
Residual Motor Block	Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)	24 hours and 48 hours
Sleep Disturbance	Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)	24 hours and 48 hours
Patients Overall Satisfaction	categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others	48 hours

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Veronique Brulotte, MD MSc FRCPC, Maisonneuve-Rosemont Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: dexaISB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES