Trial Outcomes & Findings for Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks (NCT NCT00912873)

NCT ID: NCT00912873

Last Updated: 2021-03-11

Results Overview

Quadriceps femoris muscle strength evaluated using a portable, hand-held, isometric force dynamometer (MicroFET2, Lafayette Instrument Company, Lafayette, IN) to measure the maximum voluntary isometric contraction (MVIC) in a seated position. The study primary endpoint will be the difference in MVIC the morning following surgery compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC: (preop - postop ) / preop x 100.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

The study primary endpoint will be the difference in MVIC the morning following surgery compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC: (preop - postop ) / preop x 100.

Results posted on

2021-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	0.1% Ropivicaine ropivicaine 0.1% infusion at 12 mL/hour	0.4% Ropivicaine ropivicaine 0.4% infusion at 3 mL/hour
Overall Study STARTED	26	24
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.1% Ropivicaine n=26 Participants ropivicaine 0.1% infusion at 3 mL/hour	0.4% Ropivicaine n=24 Participants ropivicaine 0.4% infusion at 3 mL/hour	Total n=50 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 3 • n=99 Participants	52 years STANDARD_DEVIATION 4 • n=107 Participants	52.5 years STANDARD_DEVIATION 3.5 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	9 Participants n=107 Participants	20 Participants n=206 Participants
Sex: Female, Male Male	15 Participants n=99 Participants	15 Participants n=107 Participants	30 Participants n=206 Participants
Region of Enrollment United States	26 Participants n=99 Participants	24 Participants n=107 Participants	50 Participants n=206 Participants

PRIMARY outcome

Timeframe: The study primary endpoint will be the difference in MVIC the morning following surgery compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC: (preop - postop ) / preop x 100.

Quadriceps femoris muscle strength evaluated using a portable, hand-held, isometric force dynamometer (MicroFET2, Lafayette Instrument Company, Lafayette, IN) to measure the maximum voluntary isometric contraction (MVIC) in a seated position. The study primary endpoint will be the difference in MVIC the morning following surgery compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC: (preop - postop ) / preop x 100.

Outcome measures

Outcome measures
Measure	0.1% Ropivicaine n=26 Participants 0.1% Ropivicaine at 12 mL/h	0.4% Ropivicaine n=24 Participants 0.4% Ropivicaine at 3 mL/h
Percent Change From Baseline in Quadriceps Femoris Maximum Voluntary Isometric Contraction (MVIC)	64.1 percentage change from baseline of MVIC Standard Error 6.4	68 percentage change from baseline of MVIC Standard Error 5.4

SECONDARY outcome

Timeframe: Day following surgery

The 100-foot walking test simply measures the amount of time it takes patients to ambulate 100 feet. Patients will be allowed to slow or stop and rest during the walk, but will be asked to resume walking as soon as they feel they are able to.

Outcome measures

Outcome measures
Measure	0.1% Ropivicaine n=26 Participants 0.1% Ropivicaine at 12 mL/h	0.4% Ropivicaine n=24 Participants 0.4% Ropivicaine at 3 mL/h
Ambulation 100-foot Walking Test Afternoon	4.0 minutes Standard Error 0.3	3.6 minutes Standard Error 0.3
Ambulation 100-foot Walking Test Morning	4.6 minutes Standard Error 0.3	5.3 minutes Standard Error 0.2

SECONDARY outcome

Timeframe: Day following surgery

Patients will be allowed to slow or stop and rest during the walk, but will be asked to resume walking as soon as they feel they are able to and go as far as they comfortable walking.

Outcome measures

Outcome measures
Measure	0.1% Ropivicaine n=26 Participants 0.1% Ropivicaine at 12 mL/h	0.4% Ropivicaine n=24 Participants 0.4% Ropivicaine at 3 mL/h
Total Ambulation morning	136 meters Standard Error 23	119 meters Standard Error 16
Total Ambulation afternoon	223 meters Standard Error 43	214 meters Standard Error 36

SECONDARY outcome

Timeframe: Day following surgery

Evaluated in the supine position using a portable, hand-held, isometric force dynamometer (MicroFET2, Lafayette Instrument Company, Lafayette, IN). The endpoint will be the difference the morning following surgery compared with the preoperative value, expressed as a percentage of the preoperative value: (preop - postop ) / preop x 100.

Outcome measures

Outcome measures
Measure	0.1% Ropivicaine n=26 Participants 0.1% Ropivicaine at 12 mL/h	0.4% Ropivicaine n=24 Participants 0.4% Ropivicaine at 3 mL/h
Percent Change From Baseline in Hip Flexion morning	69 percentage change from baseline hip flex Standard Error 4	67 percentage change from baseline hip flex Standard Error 3
Percent Change From Baseline in Hip Flexion afternoon	75 percentage change from baseline hip flex Standard Error 3	78 percentage change from baseline hip flex Standard Error 36

SECONDARY outcome

Timeframe: Day following surgery

Pain level evaluated using a verbal rating scale of 0-10, with 0=no pain and 10=worst imaginable pain

Outcome measures

Outcome measures
Measure	0.1% Ropivicaine n=26 Participants 0.1% Ropivicaine at 12 mL/h	0.4% Ropivicaine n=24 Participants 0.4% Ropivicaine at 3 mL/h
Mean Resting Pain	3.2 units on a scale Standard Error 0.4	3.2 units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Day following surgery

Pain evaluated during physical therapy using a verbal rating scale of 0-10, with 0=no pain and 10=worst imaginable pain

Outcome measures

Outcome measures
Measure	0.1% Ropivicaine n=26 Participants 0.1% Ropivicaine at 12 mL/h	0.4% Ropivicaine n=24 Participants 0.4% Ropivicaine at 3 mL/h
Average Dynamic Pain afternoon	3.2 units on a scale Standard Error 0.4	2.9 units on a scale Standard Error 0.3
Average Dynamic Pain morning	3.8 units on a scale Standard Error 0.4	3.8 units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Day following surgery

The worst pain experienced during physical therapy evaluated using a verbal rating scale of 0-10, with 0=no pain and 10=worst imaginable pain

Outcome measures

Outcome measures
Measure	0.1% Ropivicaine n=26 Participants 0.1% Ropivicaine at 12 mL/h	0.4% Ropivicaine n=24 Participants 0.4% Ropivicaine at 3 mL/h
Worst Dynamic Pain morning	6.2 score on a scale Standard Error 0.5	6.5 score on a scale Standard Error 0.5
Worst Dynamic Pain afternoon	4.3 score on a scale Standard Error 0.4	5.0 score on a scale Standard Error 0.6

Adverse Events

0.1% Ropivicaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.4% Ropivicaine

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

Brian Ilfeld, MD, MS

University California San Diego

Phone: (858) 822-0776

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place