Trial Outcomes & Findings for Nonopioid Analgesia After Rotator Cuff Repair (NCT NCT03818919)
NCT ID: NCT03818919
Last Updated: 2024-04-02
Results Overview
Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
day 10 post-operative
Results posted on
2024-04-02
Participant Flow
Participant milestones
| Measure |
Post-Operative Non Opioid Pain Protocol
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Celecoxib: Post-Operative Non Opioid Pain Protocol
Ketorolac: Post-Operative Non Opioid Pain Protocol
Gabapentin: Post-Operative Non Opioid Pain Protocol
Acetaminophen: Post-Operative Non Opioid Pain Protocol
Diazepam: Post-Operative Non Opioid Pain Protocol
|
Post-Operative Traditional Pain Protocol
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
17
|
23
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nonopioid Analgesia After Rotator Cuff Repair
Baseline characteristics by cohort
| Measure |
Post-Operative Non Opioid Pain Protocol
n=17 Participants
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Celecoxib: Post-Operative Non Opioid Pain Protocol
Ketorolac: Post-Operative Non Opioid Pain Protocol
Gabapentin: Post-Operative Non Opioid Pain Protocol
Acetaminophen: Post-Operative Non Opioid Pain Protocol
Diazepam: Post-Operative Non Opioid Pain Protocol
|
Post-Operative Traditional Pain Protocol
n=23 Participants
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
Total
n=40 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
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
BMI
|
32.2 kg/m2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
29.9 kg/m2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
30.8 kg/m2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Preoperative block
Supraclavicular
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Preoperative block
Interscalene
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Tear size
less than 1 cm
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Tear size
1-3cm
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Tear size
3-5cm
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Tear size
greater than 5cm
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tendons involved in surgery
|
1.7 number of tendons involved
STANDARD_DEVIATION 0.4 • n=5 Participants
|
1.4 number of tendons involved
STANDARD_DEVIATION 0.8 • n=7 Participants
|
1.55 number of tendons involved
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Concomitant procedures
None
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Concomitant procedures
Biceps Tenotomy
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Concomitant procedures
Biceps Tenodesis
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Concomitant procedures
DCE
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Concomitant procedures
SAD
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Anchors used in Surgery
|
2.7 number of anchors used
STANDARD_DEVIATION 0.8 • n=5 Participants
|
2.6 number of anchors used
STANDARD_DEVIATION 1.1 • n=7 Participants
|
2.6 number of anchors used
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: day 10 post-operativePatients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control.
Outcome measures
| Measure |
Post-Operative Non Opioid Pain Protocol
n=17 Participants
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Celecoxib: Post-Operative Non Opioid Pain Protocol
Ketorolac: Post-Operative Non Opioid Pain Protocol
Gabapentin: Post-Operative Non Opioid Pain Protocol
Acetaminophen: Post-Operative Non Opioid Pain Protocol
Diazepam: Post-Operative Non Opioid Pain Protocol
|
Post-Operative Traditional Pain Protocol
n=23 Participants
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Pain Levels
|
2.4 units on a scale
Standard Deviation 2.1
|
3 units on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: day 10 post-operativePatient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference.
Outcome measures
| Measure |
Post-Operative Non Opioid Pain Protocol
n=17 Participants
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Celecoxib: Post-Operative Non Opioid Pain Protocol
Ketorolac: Post-Operative Non Opioid Pain Protocol
Gabapentin: Post-Operative Non Opioid Pain Protocol
Acetaminophen: Post-Operative Non Opioid Pain Protocol
Diazepam: Post-Operative Non Opioid Pain Protocol
|
Post-Operative Traditional Pain Protocol
n=23 Participants
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System
|
59.3 units on a scale
Standard Deviation 8.5
|
60.0 units on a scale
Standard Deviation 9.3
|
Adverse Events
Post-Operative Non Opioid Pain Protocol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Post-Operative Traditional Pain Protocol
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Post-Operative Non Opioid Pain Protocol
n=17 participants at risk
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Celecoxib: Post-Operative Non Opioid Pain Protocol
Ketorolac: Post-Operative Non Opioid Pain Protocol
Gabapentin: Post-Operative Non Opioid Pain Protocol
Acetaminophen: Post-Operative Non Opioid Pain Protocol
Diazepam: Post-Operative Non Opioid Pain Protocol
|
Post-Operative Traditional Pain Protocol
n=23 participants at risk
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Gastrointestinal disorders
GI adverse effects
|
47.1%
8/17 • 10 days postop
|
43.5%
10/23 • 10 days postop
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place