Trial Outcomes & Findings for The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine (NCT NCT02497040)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

220+-70 minutes

Results posted on

2018-01-05

Participant milestones
Measure	Bupivacaine,Levobupivacaine 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection	Levobupivacaine 20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection	Bupivacaine 20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection
Overall Study STARTED	30	30	30
Overall Study COMPLETED	30	30	30
Overall Study NOT COMPLETED	0	0	0

Withdrawal data not reported

The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine

Baseline characteristics by cohort
Measure	Bupivacaine,Levobupivacaine n=30 Participants 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection	Levobupivacaine n=30 Participants 20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection	Bupivacaine n=30 Participants 20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	78 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Region of Enrollment Turkey	30 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	90 participants n=4 Participants

Timeframe: 220+-70 minutes

Outcome measures
Measure	Bupivacaine,Levobupivacaine n=30 Participants 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection	Levobupivacaine n=30 Participants 20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection	Bupivacaine n=30 Participants 20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection
Change in Mean Arterial Pressure	110 mmHg Standard Deviation 20	105 mmHg Standard Deviation 20	100 mmHg Standard Deviation 20

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Bupivacaine,Levobupivacaine n=30 participants at risk 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine Levobupivacaine: local injection Bupivacaine: local injection	Levobupivacaine n=30 participants at risk 20 ml of 0.5% levobupivacaine saline as a placebo Levobupivacaine: local injection placebo: local injection	Bupivacaine n=30 participants at risk 20 ml of 0.5% levobupivacaine saline as a placebo Bupivacaine: local injection placebo: local injection
Cardiac disorders nause, vomitting,hypertensıon	0.00% 0/30	0.00% 0/30	0.00% 0/30

uludag university

Phone: +905323827044