Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412657
• Other study ID #: dexaISB
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2018
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• Normal Saline

Locations

Country	Name	City	State
Canada	Hopital Pierre-Boucher	Longueuil	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Hopital Hotel-Dieu de Sorel	Sorel	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Analgesia	Defined as the time between the performance of the block and the first analgesic request	48 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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