Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

• Sponsor: Maisonneuve-Rosemont Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02412657
• Collaborator: (none)
• Enrollment: 75
• Locations: 3
• Arms: 3
• Duration (Months): 14
• Patients Per Site: 25
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Dexamethasone; Drug: Normal Saline	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2014
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Duration of Analgesia [48 hours after surgery]

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

Secondary Outcome Measures

1. Pain Scores [every 6 hours during the first 48 hours after surgery]

   On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)

2. Residual Motor Block [24 hours and 48 hours]

   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)

3. Sleep Disturbance [24 hours and 48 hours]

   Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)

4. Patients Overall Satisfaction [48 hours]

   categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Pierre-Boucher	Longueuil	Quebec	Canada	J4M 2A5
2	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 4M5
3	Hopital Hotel-Dieu de Sorel	Sorel	Quebec	Canada	J3P 1N5

Sponsors and Collaborators

• Maisonneuve-Rosemont Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Veronique Brulotte, Dre Veronique Brulotte, MD, M.Sc, FRCPC, anesthesiologist, Maisonneuve-Rosemont Hospital
• ClinicalTrials.gov Identifier: NCT02412657
• Other Study ID Numbers: dexaISB
• First Posted: Apr 9, 2015
• Last Update Posted: Sep 13, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Dexamethasone

Study Results

Participant Flow

Arm/Group Title	Dexamethasone 10 mg Intravenous	Dexamethasone 4 mg Intravenous	Normal Saline 20 mL Intravenous
Arm/Group Description	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 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.	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 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 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline
Period Title: Overall Study
STARTED	25	25	25
COMPLETED	24	23	22
NOT COMPLETED	1	2	3

Baseline Characteristics

Arm/Group Title	Dexamethasone 10 mg Intravenous	Dexamethasone 4 mg Intravenous	Normal Saline 20 mL Intravenous	Total
Arm/Group Description	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 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.	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 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 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline	Total of all reporting groups
Overall Participants	24	23	22	69
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	49	54	55	53
Sex: Female, Male (Count of Participants)
Female	7 29.2%	11 47.8%	11 50%	29 42%
Male	17 70.8%	12 52.2%	11 50%	40 58%
Region of Enrollment (participants) [Number]
Canada	24 100%	23 100%	22 100%	69 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 10 mg Intravenous	Dexamethasone 4 mg Intravenous	Normal Saline 20 mL Intravenous
Arm/Group Description	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 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.	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 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 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline
Measure Participants	24	23	22
Median (Inter-Quartile Range) [hours]	19.1	19.6	11.8

2. Secondary Outcome

Title	Pain Scores
Description	On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)
Time Frame	every 6 hours during the first 48 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Residual Motor Block
Description	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)
Time Frame	24 hours and 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Sleep Disturbance
Description	Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)
Time Frame	24 hours and 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Patients Overall Satisfaction
Description	categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Dexamethasone 10 mg Intravenous		Dexamethasone 4 mg Intravenous		Normal Saline 20 mL Intravenous
Arm/Group Description	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 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.		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 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 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline
All Cause Mortality
	Dexamethasone 10 mg Intravenous		Dexamethasone 4 mg Intravenous		Normal Saline 20 mL Intravenous
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexamethasone 10 mg Intravenous		Dexamethasone 4 mg Intravenous		Normal Saline 20 mL Intravenous
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone 10 mg Intravenous		Dexamethasone 4 mg Intravenous		Normal Saline 20 mL Intravenous
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/23 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.