Trial Outcomes & Findings for Exparel as a Nerve Block for Severe Hand Pain (NCT NCT02374320)

Results Overview

Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

13 participants

Primary outcome timeframe

1 hour

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Exparel (Bupivacaine Liposome Injectable Suspension) 20 mL Exparel (bupivacaine liposome injectable suspension) injected once liposomal bupivacaine: injected as an axillary block
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	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 n=13 Participants 20 mL liposomal bupivacaine injected once liposomal bupivacaine: injected as an axillary block
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants
Sex: Female, Male Female	10 Participants n=13 Participants
Sex: Female, Male Male	3 Participants n=13 Participants
Region of Enrollment United States	13 Participants n=13 Participants

PRIMARY outcome

Timeframe: 1 hour

Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.

Outcome measures

Outcome measures
Measure	Pre-block (Baseline) n=13 Participants 20 mL liposomal bupivacaine injected once liposomal bupivacaine: injected as an axillary block	One Hour Post Block n=13 Participants
Radial and Ulnar Arterial Diameter Ulnar artery diameter	0.16 centimeters Interval 0.07 to 0.234	.20 centimeters Interval 0.107 to 0.254
Radial and Ulnar Arterial Diameter Radial artery diameter	0.19 centimeters Interval 0.15 to 0.234	0.23 centimeters Interval 0.15 to 0.336

SECONDARY outcome

Timeframe: 1 month

Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable)

Outcome measures

Outcome measures
Measure	Pre-block (Baseline) n=13 Participants 20 mL liposomal bupivacaine injected once liposomal bupivacaine: injected as an axillary block	One Hour Post Block n=13 Participants
Pain Measured by Numerical Rating Scale	6.0 units on a scale Interval 2.0 to 10.0	5.2 units on a scale Interval 0.0 to 10.0

Adverse Events

Exparel

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