Trial Outcomes & Findings for Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale (NCT NCT00956709)

NCT ID: NCT00956709

Last Updated: 2016-10-05

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2016-10-05

Participant Flow

Participant milestones

Measure	Levobupivacaïne 0,5 % levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %	Ropivacaïne 0,5% ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
Overall Study STARTED	16	19
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale

Baseline characteristics by cohort

Measure	Levobupivacaïne 0,5 % n=16 Participants levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %	Ropivacaïne 0,5% n=19 Participants ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %	Total n=35 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment France	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Two patients in each group had incomplete block before surgery.

Outcome measures

Measure	Levobupivacaïne 0,5 % n=16 Participants levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %	Ropivacaïne 0,5% n=19 Participants ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot	40 minutes Interval 15.0 to 60.0	35 minutes Interval 10.0 to 60.0

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Levobupivacaïne 0,5 % n=16 Participants levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %	Ropivacaïne 0,5% n=19 Participants ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
Duration of Motor Sciatic Block (h)	15.54 hours Interval 5.25 to 37.5	15.17 hours Interval 4.42 to 20.5

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Levobupivacaïne 0,5 % n=16 Participants levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %	Ropivacaïne 0,5% n=19 Participants ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
Duration of Sensory Sciatic Block (h)	17.25 hours Interval 6.25 to 53.5	15.00 hours Interval 8.52 to 23.67

Adverse Events

Levobupivacaïne 0,5 %

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaïne 0,5%

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 Pham Dang

CHU de Nantes

Phone: 33 2 53 48 24 15

Email: charles.phamdang@chu-nantes.fr

Results disclosure agreements

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