Trial Outcomes & Findings for A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty (NCT NCT05053087)
NCT ID: NCT05053087
Last Updated: 2024-02-22
Results Overview
Patient self-reported pain intensity score measured on the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
14 days post-operatively
Results posted on
2024-02-22
Participant Flow
Participant milestones
| Measure |
Single Shot Adductor Canal
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Placebo: Saline filled catheter
|
Ropivacaine Continuous
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
Ropivacaine Continuous Infusion: 0.2% continuous infusion 6mL/hr
|
Ropivacaine Intermittent Bolus
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
Ropivacaine Intermittent Bolus: 0.2% intermittent bolus infusion 8mL every 2 hours
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
19
|
|
Overall Study
COMPLETED
|
21
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Single Shot Adductor Canal
n=21 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Placebo: Saline filled catheter
|
Ropivacaine Continuous
n=20 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
Ropivacaine Continuous Infusion: 0.2% continuous infusion 6mL/hr
|
Ropivacaine Intermittent Bolus
n=19 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
Ropivacaine Intermittent Bolus: 0.2% intermittent bolus infusion 8mL every 2 hours
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75 years
n=5 Participants
|
71 years
n=7 Participants
|
70 years
n=5 Participants
|
72 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 days post-operativelyPatient self-reported pain intensity score measured on the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.
Outcome measures
| Measure |
Single Shot Adductor Canal
n=21 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Placebo: Saline filled catheter
|
Ropivacaine Continuous
n=20 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
Ropivacaine Continuous Infusion: 0.2% continuous infusion 6mL/hr
|
Ropivacaine Intermittent Bolus
n=19 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
Ropivacaine Intermittent Bolus: 0.2% intermittent bolus infusion 8mL every 2 hours
|
|---|---|---|---|
|
Post-operative Pain Levels
|
5.1 score on a scale
Interval 1.7 to 7.9
|
5.1 score on a scale
Interval 3.1 to 8.3
|
6.1 score on a scale
Interval 1.9 to 8.0
|
SECONDARY outcome
Timeframe: 60 days, or until discontinuation of narcotic medication (whichever is later)Amount of medication administered via the patient-controlled function on the adductor catheter
Outcome measures
| Measure |
Single Shot Adductor Canal
n=21 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Placebo: Saline filled catheter
|
Ropivacaine Continuous
n=20 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
Ropivacaine Continuous Infusion: 0.2% continuous infusion 6mL/hr
|
Ropivacaine Intermittent Bolus
n=19 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
Ropivacaine Intermittent Bolus: 0.2% intermittent bolus infusion 8mL every 2 hours
|
|---|---|---|---|
|
Amount of Medication Administered
|
138 mL
Interval 18.0 to 222.0
|
111 mL
Interval 6.0 to 222.0
|
144 mL
Interval 24.0 to 240.0
|
SECONDARY outcome
Timeframe: 60 days, or until discontinuation of narcotic medication (whichever is later)Number of days that narcotic use was required.
Outcome measures
| Measure |
Single Shot Adductor Canal
n=21 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Placebo: Saline filled catheter
|
Ropivacaine Continuous
n=20 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
Ropivacaine Continuous Infusion: 0.2% continuous infusion 6mL/hr
|
Ropivacaine Intermittent Bolus
n=19 Participants
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
Ropivacaine Intermittent Bolus: 0.2% intermittent bolus infusion 8mL every 2 hours
|
|---|---|---|---|
|
Duration of Narcotic Used
|
21 days
Interval 1.0 to 60.0
|
14 days
Interval 5.0 to 60.0
|
14 days
Interval 2.0 to 60.0
|
Adverse Events
Single Shot Adductor Canal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine Continuous
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ropivacaine Intermittent Bolus
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Shot Adductor Canal
n=21 participants at risk
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Placebo: Saline filled catheter
|
Ropivacaine Continuous
n=20 participants at risk
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
Ropivacaine Continuous Infusion: 0.2% continuous infusion 6mL/hr
|
Ropivacaine Intermittent Bolus
n=19 participants at risk
Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
Ropivacaine Intermittent Bolus: 0.2% intermittent bolus infusion 8mL every 2 hours
|
|---|---|---|---|
|
Surgical and medical procedures
Catheter removed early
|
0.00%
0/21 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
10.0%
2/20 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
5.3%
1/19 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
|
Surgical and medical procedures
Catheter placed incorrectly
|
0.00%
0/21 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
0.00%
0/20 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
5.3%
1/19 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
|
General disorders
Fever
|
0.00%
0/21 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
0.00%
0/20 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
5.3%
1/19 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
|
Musculoskeletal and connective tissue disorders
Knew swelling
|
0.00%
0/21 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
5.0%
1/20 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
0.00%
0/19 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
|
Musculoskeletal and connective tissue disorders
Knee bruising
|
0.00%
0/21 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
5.0%
1/20 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
0.00%
0/19 • Adverse events were collected from baseline to end of study, approximately, 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place