Trial Outcomes & Findings for Multicenter Continuous Peripheral Nerve Block Surveillance Study (NCT NCT00653133)

Last Updated: 2018-10-02

Results Overview

Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic

Recruitment status

COMPLETED

Study phase

Target enrollment

1821 participants

Primary outcome timeframe

Preoperative through 3 days post operative

Results posted on

2018-10-02

Participant milestones
Measure	USPNB ultrasound imaging guided peripheral nerve block	NSPNB Stimulator guided nerve block
Overall Study STARTED	1324	497
Overall Study COMPLETED	1324	497
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Multicenter Continuous Peripheral Nerve Block Surveillance Study

Baseline characteristics by cohort
Measure	USPNB n=1324 Participants ultrasound imaging guided peripheral nerve block	NSPNB n=497 Participants Stimulator guided nerve block	Total n=1821 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	0 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	843 Participants n=5 Participants	306 Participants n=7 Participants	1149 Participants n=5 Participants
Age, Categorical >=65 years	469 Participants n=5 Participants	191 Participants n=7 Participants	660 Participants n=5 Participants
Age, Continuous	57.1 years STANDARD_DEVIATION 16.4 • n=5 Participants	57.7 years STANDARD_DEVIATION 17.2 • n=7 Participants	57.3 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	649 Participants n=5 Participants	214 Participants n=7 Participants	863 Participants n=5 Participants
Sex: Female, Male Male	675 Participants n=5 Participants	283 Participants n=7 Participants	958 Participants n=5 Participants
Region of Enrollment United States	1324 participants n=5 Participants	497 participants n=7 Participants	1821 participants n=5 Participants

Timeframe: Preoperative through 3 days post operative

Population: Intent to treat (ITT)

Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic

Outcome measures
Measure	USPNB n=1324 Participants Ultrasound imaging guided peripheral nerve block	NSPNB n=497 Participants Nerve Stimulator guided peripheral nerve block
Complications of Peripheral Nerve Block	7 participants	14 participants

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	USPNB n=1324 participants at risk ultrasound imaging guided peripheral nerve block	NSPNB n=497 participants at risk Stimulator guided nerve block
Vascular disorders VASCULAR PUNCTURE	0.30% 4/1324 • Number of events 4 • 7 days postoperative	1.6% 8/497 • Number of events 8 • 7 days postoperative
Infections and infestations Infection	0.15% 2/1324 • Number of events 2 • 7 days postoperative	0.40% 2/497 • Number of events 2 • 7 days postoperative
Nervous system disorders motor block	0.08% 1/1324 • Number of events 1 • 7 days postoperative	0.80% 4/497 • Number of events 4 • 7 days postoperative

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