Trial Outcomes & Findings for Adductor Canal Catheter Effectiveness and Safety Study (NCT NCT04639128)

NCT ID: NCT04639128

Last Updated: 2024-04-25

Results Overview

Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 126 participants
• Primary outcome timeframe: Second postoperative day
• Results posted on: 2024-04-25

Participant Flow

Participant milestones

Measure	No-Device No placement of an adductor canal catheter	Device Placement of an adductor canal catheter Adductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days
Overall Study STARTED	63	63
Overall Study COMPLETED	60	62
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adductor Canal Catheter Effectiveness and Safety Study

Baseline characteristics by cohort

Measure	No-Device n=63 Participants No placement of an adductor canal catheter	Device n=63 Participants Placement of an adductor canal catheter Adductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days	Total n=126 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 8.6 • n=5 Participants	66.5 years STANDARD_DEVIATION 9.3 • n=7 Participants	66.5 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	37 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants	63 participants n=7 Participants	126 participants n=5 Participants

PRIMARY outcome

Timeframe: Second postoperative day

Population: Had surgery and able to provide postoperative day-2 pain score

Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain

Outcome measures

Measure	No-Device n=60 Participants No placement of an adductor canal catheter	Device n=62 Participants Placement of an adductor canal catheter Adductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days
Pain Numerical Rating Scale	6.38 score on a scale Standard Error 0.30	5.31 score on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: 15 postoperative days

Population: Numbers of participants do not equal those of the pain-score analyses due to missing data

Total number of 5mg oxycodone tablets (provided to all patients on discharge) consumed over the 15-day postoperative period as recorded in the daily pain-and-medication postoperative diary

Outcome measures

Measure	No-Device n=47 Participants No placement of an adductor canal catheter	Device n=46 Participants Placement of an adductor canal catheter Adductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days
Opioid Consumption in the 15-day Postoperative Period	41.9 5mg oxycodone tablets Standard Error 4.20	46.0 5mg oxycodone tablets Standard Error 5.59

Adverse Events

No-Device

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Device

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	No-Device n=63 participants at risk No placement of an adductor canal catheter	Device n=63 participants at risk Placement of an adductor canal catheter Adductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days
Nervous system disorders Vertigo	0.00% 0/63 • 30 days postoperatively	1.6% 1/63 • Number of events 1 • 30 days postoperatively
Gastrointestinal disorders Small-bowel obstruction	1.6% 1/63 • Number of events 1 • 30 days postoperatively	0.00% 0/63 • 30 days postoperatively
Cardiac disorders Atrial fibrillation	1.6% 1/63 • Number of events 1 • 30 days postoperatively	0.00% 0/63 • 30 days postoperatively
Skin and subcutaneous tissue disorders Wound dehiscence	1.6% 1/63 • Number of events 1 • 30 days postoperatively	0.00% 0/63 • 30 days postoperatively

Other adverse events

Adverse event data not reported

Additional Information

Dr. Adrian Hinman

The Permanente Medical Group

Phone: 510-454-7292

Email: adrian.d.hinman@kp.org

Results disclosure agreements

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