Trial Outcomes & Findings for Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (NCT NCT03818932)
NCT ID: NCT03818932
Last Updated: 2026-03-19
Results Overview
Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected once preoperatively and at 10 days postoperatively. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. 0 is equivalent to no physical function and 100 is equivalent to total physical function.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
90 participants
Primary outcome timeframe
From preoperative visit to 10 days post-operatively
Results posted on
2026-03-19
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
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
28
|
34
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
Baseline characteristics by cohort
| Measure |
Post-Operative Non Opioid Pain Protocol
n=34 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=28 Participants
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=110 Participants
|
28 Participants
n=114 Participants
|
62 Participants
n=224 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 13.1 • n=110 Participants
|
27.4 years
STANDARD_DEVIATION 12.4 • n=114 Participants
|
27.3 years
STANDARD_DEVIATION 12.7 • n=224 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=110 Participants
|
13 Participants
n=114 Participants
|
28 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=110 Participants
|
15 Participants
n=114 Participants
|
34 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
19 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=110 Participants
|
12 Participants
n=114 Participants
|
27 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=110 Participants
|
10 Participants
n=114 Participants
|
13 Participants
n=224 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=110 Participants
|
28 participants
n=114 Participants
|
62 participants
n=224 Participants
|
PRIMARY outcome
Timeframe: 10 days post-operativelyPatients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale is a validated measure for pain where 0 is no pain and 10 is the 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=34 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=28 Participants
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Pain Levels Using the Visual Analog Scale
|
2.5 score on a scale (0-10 on VAS pain scale
Interval 2.29 to 2.71
|
4.06 score on a scale (0-10 on VAS pain scale
Interval 3.85 to 4.27
|
PRIMARY outcome
Timeframe: From preoperative visit to 10 days post-operativelyPatient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected once preoperatively and at 10 days postoperatively. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. 0 is equivalent to no physical function and 100 is equivalent to total physical function.
Outcome measures
| Measure |
Post-Operative Non Opioid Pain Protocol
n=34 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=28 Participants
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System
|
61.4 score on a scale
Standard Deviation 8.9
|
66.3 score on a scale
Standard Deviation 8.2
|
Adverse Events
Post-Operative Non Opioid Pain Protocol
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Post-Operative Traditional Pain Protocol
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Post-Operative Non Opioid Pain Protocol
n=34 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=28 participants at risk
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen
Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
35.3%
12/34 • 10 days postop
|
46.4%
13/28 • 10 days postop
|
|
Gastrointestinal disorders
Nausea
|
26.5%
9/34 • 10 days postop
|
35.7%
10/28 • 10 days postop
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
2/34 • 10 days postop
|
7.1%
2/28 • 10 days postop
|
|
Gastrointestinal disorders
Upset Stomach
|
23.5%
8/34 • 10 days postop
|
32.1%
9/28 • 10 days postop
|
|
Gastrointestinal disorders
Drowsy
|
52.9%
18/34 • 10 days postop
|
42.9%
12/28 • 10 days postop
|
|
Nervous system disorders
Loopy
|
35.3%
12/34 • 10 days postop
|
14.3%
4/28 • 10 days postop
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place