Trial Outcomes & Findings for Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block (NCT NCT02412657)

NCT ID: NCT02412657

Last Updated: 2018-09-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 48 hours after surgery
• Results posted on: 2018-09-13

Participant Flow

Participant milestones

Measure	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 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 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 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 Intravenous Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline
Overall Study STARTED	25	25	25
Overall Study COMPLETED	24	23	22
Overall Study NOT COMPLETED	1	2	3

Reasons for withdrawal

Measure	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 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 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 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 Intravenous Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline
Overall Study Lost to Follow-up	1	0	0
Overall Study Protocol Violation	0	2	3

Baseline Characteristics

Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

Baseline characteristics by cohort

Measure	Dexamethasone 10 mg Intravenous n=24 Participants 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 Intravenous n=23 Participants 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 Intravenous n=22 Participants Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline	Total n=69 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	54 years n=7 Participants	55 years n=5 Participants	53 years n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	40 Participants n=4 Participants
Region of Enrollment Canada	24 participants n=5 Participants	23 participants n=7 Participants	22 participants n=5 Participants	69 participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours after surgery

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

Outcome measures

Measure	Dexamethasone 10 mg Intravenous n=24 Participants 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 Intravenous n=23 Participants 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 Intravenous n=22 Participants Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Normal Saline
Duration of Analgesia	19.1 hours Interval 11.5 to 22.8	19.6 hours Interval 16.0 to 22.2	11.8 hours Interval 8.7 to 13.8

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours and 48 hours

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Dexamethasone 10 mg Intravenous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone 4 mg Intravenous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline 20 mL Intravenous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Veronique Brulotte

MaisonneuveRH

Phone: (514)252-3400

Email: veronique.brulotte@umontreal.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place