Trial Outcomes & Findings for Rotator Cuff Pathway (NCT NCT03717753)
NCT ID: NCT03717753
Last Updated: 2024-12-27
Results Overview
worst NRS with movement. A lower score is a better outcome. The score range is between 0 and 10.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
0-48 hours after block placement
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Before Group
We plan to have 70 patients studied prior to initiation of a pathway.
|
After Group
We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
70
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rotator Cuff Pathway
Baseline characteristics by cohort
| Measure |
Before Group
n=70 Participants
We plan to have 70 patients studied prior to initiation of a pathway.
|
After Group
n=70 Participants
We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 12 • n=5 Participants
|
59 years
STANDARD_DEVIATION 10 • n=7 Participants
|
57 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
70 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
ASA Level
ASA I
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
ASA Level
ASA II
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
ASA Level
ASA III
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
BMI
|
27.8 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Procedure Time
|
47 minutes
STANDARD_DEVIATION 16 • n=5 Participants
|
57 minutes
STANDARD_DEVIATION 18 • n=7 Participants
|
52 minutes
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Rotator Cuff Repair Performed
|
59 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-48 hours after block placementworst NRS with movement. A lower score is a better outcome. The score range is between 0 and 10.
Outcome measures
| Measure |
Before Group
n=70 Participants
We plan to have 70 patients studied prior to initiation of a pathway.
|
After Group
n=70 Participants
We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
|
|---|---|---|
|
Primary Outcome - Worst NRS With Movement
Post-Op Day 1
|
5.6 score on a scale
Standard Deviation 3
|
3.3 score on a scale
Standard Deviation 3.1
|
|
Primary Outcome - Worst NRS With Movement
Post-Op Day 2
|
6.1 score on a scale
Standard Deviation 2.7
|
6.4 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Post Op Days 1,2,7,14Population: some patients were lost to follow up.
The total opioid consumption measured in morphine milligram equivalents (MME). Although recorded at different time points, the total MME per patient was calculated.
Outcome measures
| Measure |
Before Group
n=70 Participants
We plan to have 70 patients studied prior to initiation of a pathway.
|
After Group
n=70 Participants
We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
|
|---|---|---|
|
Total Opioid Use
0-24 hours
|
15 morphine equivalent units (mg)
Interval 7.5 to 30.0
|
0 morphine equivalent units (mg)
Interval 0.0 to 7.5
|
|
Total Opioid Use
24-48 hours
|
22.5 morphine equivalent units (mg)
Interval 15.0 to 45.0
|
15 morphine equivalent units (mg)
Interval 7.5 to 30.0
|
|
Total Opioid Use
POD7
|
0 morphine equivalent units (mg)
Interval 0.0 to 7.5
|
0 morphine equivalent units (mg)
Interval 0.0 to 0.0
|
|
Total Opioid Use
POD14
|
0 morphine equivalent units (mg)
Interval 0.0 to 0.0
|
0 morphine equivalent units (mg)
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post Op Days 1,2,7,14Population: Some patients were lost to follow up.
Measures the patient's satisfaction with their pain management on a scale of 0-10. A higher score is a better outcome.
Outcome measures
| Measure |
Before Group
n=70 Participants
We plan to have 70 patients studied prior to initiation of a pathway.
|
After Group
n=70 Participants
We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
|
|---|---|---|
|
Patient Satisfaction With Pain Management
POD0
|
9.6 score on a scale
Standard Deviation 1.4
|
9.5 score on a scale
Standard Deviation 1.6
|
|
Patient Satisfaction With Pain Management
POD1
|
8.2 score on a scale
Standard Deviation 2.5
|
9.2 score on a scale
Standard Deviation 1.7
|
|
Patient Satisfaction With Pain Management
POD2
|
8.6 score on a scale
Standard Deviation 1.6
|
8.8 score on a scale
Standard Deviation 1.8
|
|
Patient Satisfaction With Pain Management
POD7
|
8.7 score on a scale
Standard Deviation 1.5
|
9.1 score on a scale
Standard Deviation 1.7
|
|
Patient Satisfaction With Pain Management
POD14
|
9 score on a scale
Standard Deviation 1.3
|
9.1 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Post Op Days 1,2,7,14a NRS score on a scale from 0 to 10. 0 means no pain and 10 is the worst pain imaginable. A lower score is a better outcome.
Outcome measures
| Measure |
Before Group
n=70 Participants
We plan to have 70 patients studied prior to initiation of a pathway.
|
After Group
n=70 Participants
We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
|
|---|---|---|
|
Pain Score at Rest
Post-Op Day 1
|
4.0 score on a scale of
Standard Deviation 2.9
|
1.9 score on a scale of
Standard Deviation 2.3
|
|
Pain Score at Rest
Post-Op Day 2
|
4.2 score on a scale of
Standard Deviation 2.1
|
4.7 score on a scale of
Standard Deviation 2.8
|
|
Pain Score at Rest
Post-Op Day 7
|
2.3 score on a scale of
Standard Deviation 2.1
|
3 score on a scale of
Standard Deviation 2.4
|
|
Pain Score at Rest
Post-Op Day 14
|
2.2 score on a scale of
Standard Deviation 1.9
|
1.7 score on a scale of
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Through Post Op Day 2Population: Some patients were lost to follow up
Measures the duration of the block from: the time the block started to the time the block completely wore off the time the block started to the time the patient first noticed pain the time the block started to the time the patient felt normal sensation
Outcome measures
| Measure |
Before Group
n=70 Participants
We plan to have 70 patients studied prior to initiation of a pathway.
|
After Group
n=70 Participants
We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
|
|---|---|---|
|
Block Duration
Time to first notice pain
|
21.1 hours
Interval 13.9 to 23.6
|
25.4 hours
Interval 22.8 to 27.8
|
|
Block Duration
Time to block start to wear off
|
20.1 hours
Interval 13.9 to 23.4
|
23.2 hours
Interval 18.3 to 26.9
|
|
Block Duration
Time to block to completely wear off
|
22.7 hours
Interval 17.3 to 24.6
|
28.4 hours
Interval 24.9 to 33.1
|
|
Block Duration
Time to normal sensation
|
22.8 hours
Interval 17.7 to 26.0
|
28.6 hours
Interval 25.1 to 36.7
|
Adverse Events
Before Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
After Group
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
Dr. Jacques YaDeau, MD PhD
Hospital for Special Surgery
Phone: 212- 606-1206
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place