Trial Outcomes & Findings for Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain (NCT NCT00768248)

NCT ID: NCT00768248

Last Updated: 2019-08-13

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2019-08-13

Participant Flow

Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.

Participant milestones

Measure	Active 3-7 days of perineural local anesthetic infusion perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h	Placebo 3-7 days of perineural normal saline infusion normal saline (placebo): the basal rate will be set at 7 mL/h
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Active 3-7 days of perineural local anesthetic infusion perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h	Placebo 3-7 days of perineural normal saline infusion normal saline (placebo): the basal rate will be set at 7 mL/h
Overall Study Research coordinator didn't collect data	1	1

Baseline Characteristics

Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

Baseline characteristics by cohort

Measure	Active n=1 Participants 3-7 days of perineural local anesthetic infusion perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h	Placebo n=1 Participants 3-7 days of perineural normal saline infusion normal saline (placebo): the basal rate will be set at 7 mL/h	Total n=2 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24 years n=5 Participants	23 years n=7 Participants	23.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention, then days 1, 3, 8, 28, 84, and 365

Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention; and then day 28 and 365 post-intervention

Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-intervention; and then 8 and 28 days post-intervention

Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8, Day 28, Month 12

Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.

Outcome measures

Outcome data not reported

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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: bilfeld@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place