Trial Outcomes & Findings for Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery (NCT NCT02058303)

Results Overview

A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

30 minutes

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Exparel Forearm Block Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.	Bupivacaine Supraclavicular Block Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine
Overall Study STARTED	16	21
Overall Study COMPLETED	16	21
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	Exparel Forearm Block n=16 Participants Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.	Bupivacaine Supraclavicular Block n=21 Participants Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine	Total n=37 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 0 • n=16 Participants	62.5 years STANDARD_DEVIATION 0 • n=21 Participants	62.5 years STANDARD_DEVIATION 0 • n=37 Participants
Sex: Female, Male Female	12 Participants n=16 Participants	17 Participants n=21 Participants	29 Participants n=37 Participants
Sex: Female, Male Male	4 Participants n=16 Participants	4 Participants n=21 Participants	8 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	16 participants n=16 Participants	21 participants n=21 Participants	37 participants n=37 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: Discrepancies are due to a subset of subjects not achieving full blockade at 30 minutes.

A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.

Outcome measures

Outcome measures
Measure	Exparel Forearm Block n=16 Participants Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.	Bupivacaine Supraclavicular Block n=21 Participants Under ultrasound guidance, 20-30 milliliters (mL) 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine
Onset of Sensorimotor Block Median nerve block after 30 minutes	1.0 proportion of subjects	.81 proportion of subjects
Onset of Sensorimotor Block Ulnar nerve block after 30 minutes	.933 proportion of subjects	.818 proportion of subjects
Onset of Sensorimotor Block Radial nerve block after 30 minutes	1.0 proportion of subjects	.864 proportion of subjects
Onset of Sensorimotor Block Musculocutaneous nerve block after 30 minutes	.933 proportion of subjects	.79 proportion of subjects

Adverse Events

Exparel Forearm Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine Supraclavicular Block

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

Ken Bode

Ochsner Health System

Phone: 504.842.1936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place