Trial Outcomes & Findings for The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block (NCT NCT01272921)

Results Overview

Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

142 participants

Primary outcome timeframe

3 days

Results posted on

2017-04-06

Participant Flow

Subjects undergoing primary tricompartmental total knee replacement at Northwestern Memorial Hospital were asked to participate. 174 patients were approached. 142 subjects were recruited to participate.

Exclusion criteria: subject refusal to be included in the study, contraindications to regional anesthesia, inability to elicit an evoked motor response less than or equal to 1 mA, history of allergy to amide local anesthetics, presence of a progressive neurological deficit, opioid tolerant subjects, presence of coagulopathy, infection, or pregnancy

Participant milestones

Participant milestones
Measure	Bupivacaine Varying does to determine duration of analgesia following a sciatic nerve block Bupivacaine : Varying doses to determine the duration of analgesia	Ropivacaine Varying does to determine duration of analgesia following a sciatic nerve block Ropivacaine : Varying doses to determine the duration of analgesia
Overall Study STARTED	71	71
Overall Study COMPLETED	69	70
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Bupivacaine Varying does to determine duration of analgesia following a sciatic nerve block Bupivacaine : Varying doses to determine the duration of analgesia	Ropivacaine Varying does to determine duration of analgesia following a sciatic nerve block Ropivacaine : Varying doses to determine the duration of analgesia
Overall Study Protocol Violation	2	1

Baseline Characteristics

The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GROUP 1 n=69 Participants Varying does to determine duration of analgesia following a sciatic nerve block Bupivacaine : Varying doses to determine the duration of analgesia	GROUP 2 n=70 Participants Varying does to determine duration of analgesia following a sciatic nerve block Ropivacaine : Varying doses to determine the duration of analgesia	Total n=139 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
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Age, Continuous	66.93 years STANDARD_DEVIATION 9.21 • n=5 Participants	64.70 years STANDARD_DEVIATION 9.26 • n=7 Participants	65.81 years STANDARD_DEVIATION 9.27 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	70 participants n=7 Participants	139 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL).

Outcome measures

Outcome measures
Measure	Above CIEL n=69 Participants The mean threshold current required to elicit a motor response above the common investing extraneural layer (CIEL).	Below CIEL n=70 Participants The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL Sensory: <10ml	9 Hours Interval 6.0 to 14.0	8 Hours Interval 6.0 to 12.0
Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL Motor: < 10ml	10 Hours Interval 4.0 to 14.0	7 Hours Interval 5.0 to 10.0
Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL Motor: >/= 10ml	21 Hours Interval 17.0 to 22.0	15 Hours Interval 14.0 to 15.0
Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL Sensory: >/= 10ml	20 Hours Interval 17.0 to 23.0	14 Hours Interval 13.0 to 15.0

SECONDARY outcome

Timeframe: 1 Day

The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.

Outcome measures

Outcome measures
Measure	Above CIEL n=69 Participants The mean threshold current required to elicit a motor response above the common investing extraneural layer (CIEL).	Below CIEL n=70 Participants The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
Cumulative Probabilities for Needle Positioning Above and Below CIEL.	0.52 Amplitude (mA) Interval 0.49 to 0.54	0.19 Amplitude (mA) Interval 0.18 to 0.21

Adverse Events

GROUP 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GROUP 2

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

Mark Kendall, M.D.

Northwestern University

Phone: 312-695-2528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place