Trial Outcomes & Findings for Comparison of Levobupivacaine and Ropivacaine for Femoral Neural Block (NCT NCT01172197)

Results Overview

Number achieving pain on movement of knee measured as 0 on a verbal pain rating scale at 30h after start of perineural infusion

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

30 hours

Results posted on

2018-05-09

Participant Flow

Patients recruited on ward 24h before procedure. Patient information sheet sent to patients 3 weeks before operation

Nil to report

Participant milestones

Participant milestones
Measure	Ropivacaine Local anaesthetic bolus and infusion Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM	Levobupivacaine Local anaesthetic bolus and infusion Ropivacaine: Bolus and infusion
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropivacaine n=7 Participants Local anaesthetic bolus and infusion Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM	Levobupivacaine n=7 Participants Local anaesthetic bolus and infusion Ropivacaine: Femoral bolus 150μM followed by femoral infusion 400μM	Total n=14 Participants Total of all reporting groups
Age, Continuous	60 years n=7 Participants	64 years n=7 Participants	62 years n=14 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	2 Participants n=7 Participants	5 Participants n=14 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	5 Participants n=7 Participants	9 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	7 Participants n=7 Participants	7 Participants n=7 Participants	14 Participants n=14 Participants

PRIMARY outcome

Timeframe: 30 hours

Population: Knee replacement. All obtained pain relief defined as pain score = 0 on a verbal pain rating scale

Number achieving pain on movement of knee measured as 0 on a verbal pain rating scale at 30h after start of perineural infusion

Outcome measures

Outcome measures
Measure	Ropivacaine n=7 Participants Local anaesthetic bolus and infusion Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM	Levobupivacaine n=7 Participants Local anaesthetic bolus and infusion Ropivacaine: Bolus and infusion
Pain	7 Participants	7 Participants

Adverse Events

Ropivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Levobupivacaine

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 G McLeod

NHS Tayside

Phone: +44 1382 7974440848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place