Trial Outcomes & Findings for Supraclavicular Brachial Plexus Block Using Ropivacaine Alone and With Dexmedetomidine (NCT NCT02393677)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

upto 8 hours

Results posted on

2015-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Ropivacaine amide local anesthetic Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus	Ropivacaine With Dexmedetomidine combination of amide local anaesthetic and alpha2 agonist Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supraclavicular Brachial Plexus Block Using Ropivacaine Alone and With Dexmedetomidine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropivacaine n=40 Participants amide local anesthetic Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus	Ropivacaine With Dexmedetomidine n=40 Participants combination of amide local anaesthetic and alpha2 agonist Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus	Total n=80 Participants Total of all reporting groups
Age, Continuous	35.2 years STANDARD_DEVIATION 9.6 • n=93 Participants	34.52 years STANDARD_DEVIATION 12.8 • n=4 Participants	34.86 years STANDARD_DEVIATION 11.2 • n=27 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	23 Participants n=4 Participants	43 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	17 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment India	40 participants n=93 Participants	40 participants n=4 Participants	80 participants n=27 Participants

PRIMARY outcome

Timeframe: upto 8 hours

Outcome measures

Outcome measures
Measure	Ropivacaine n=40 Participants amide local anesthetic Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus	Ropivacaine With Dexmedetomidine n=40 Participants combination of amide local anaesthetic and alpha2 agonist Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus
Duration of Analgesia	413.73 minutes Standard Deviation 89.92	197.35 minutes Standard Deviation 28.67

SECONDARY outcome

Timeframe: 20 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

Outcome measures

Outcome data not reported

Adverse Events

Ropivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine With Dexmedetomidine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ropivacaine n=40 participants at risk amide local anesthetic Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus	Ropivacaine With Dexmedetomidine n=40 participants at risk combination of amide local anaesthetic and alpha2 agonist Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus
Gastrointestinal disorders Nausea and vomiting	0.00% 0/40	10.0% 4/40 • Number of events 4

Additional Information

Dr. Bikramjit Das

Govt. Medical College, Haldwani.

Phone: (05946)-228393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place