Trial Outcomes & Findings for Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures (NCT NCT05076110)
NCT ID: NCT05076110
Last Updated: 2026-06-03
Results Overview
The change in pain score measured using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain with higher scores indicating worsening pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
1 day post-operatively, 14 days post-operatively
Results posted on
2026-06-03
Participant Flow
Participant milestones
| Measure |
Standard of Care Group
Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure
Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control
|
Non-Opiate Pain Control Group
Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.
Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively
Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
Methocarbamol: 500 mg three times a week for 2 weeks postoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care Group
n=43 Participants
Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure
Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control
|
Non-Opiate Pain Control Group
n=43 Participants
Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.
Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively
Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
Methocarbamol: 500 mg three times a week for 2 weeks postoperatively
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 11.3 • n=43 Participants
|
33.4 years
STANDARD_DEVIATION 12.4 • n=43 Participants
|
33.0 years
STANDARD_DEVIATION 11.8 • n=86 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=43 Participants
|
26 Participants
n=43 Participants
|
57 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=43 Participants
|
17 Participants
n=43 Participants
|
29 Participants
n=86 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
43 participants
n=43 Participants
|
43 participants
n=43 Participants
|
86 participants
n=86 Participants
|
PRIMARY outcome
Timeframe: 1 day post-operatively, 14 days post-operativelyThe change in pain score measured using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain with higher scores indicating worsening pain.
Outcome measures
| Measure |
Standard of Care Group
n=43 Participants
Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure
Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control
|
Non-Opiate Pain Control Group
n=43 Participants
Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.
Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively
Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
Methocarbamol: 500 mg three times a week for 2 weeks postoperatively
|
|---|---|---|
|
Change in Pain Score
Day 14 Post-Operatively
|
1.8 score on a scale
Standard Deviation 0.2
|
1.7 score on a scale
Standard Deviation 0.1
|
|
Change in Pain Score
Day 1 Post-Operatively
|
4.3 score on a scale
Standard Deviation 0.2
|
4.4 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline; 14 days post operativelyThe PROMIS Pain Interference Score is a 6-item patient-reported measure assessing how pain disrupts daily activities. Responses are scored on a 5-point Likert scale (1= Not at all to 5= very much). Each item is scored individually, and the raw scores are summed to produce a total score. The total raw score is then converted to a T-score which standardizes the score with a mean of 50 and a standard deviation of 10 based on the general population. Higher T-scores indicate greater interference.
Outcome measures
| Measure |
Standard of Care Group
n=43 Participants
Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure
Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control
|
Non-Opiate Pain Control Group
n=43 Participants
Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.
Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively
Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
Methocarbamol: 500 mg three times a week for 2 weeks postoperatively
|
|---|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Baseline
|
61.0 score on a scale
Standard Deviation 0.9
|
62.7 score on a scale
Standard Deviation 0.9
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Day 14 Post-Operatively
|
52.3 score on a scale
Standard Deviation 1.5
|
53.4 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Day 1 Post-Operatively; Day 14 Post-OperativelyPopulation: This outcome measure was looking at opioid consumption post-operatively, due to this, this outcome measure only applied to the standard of care arm as the non-opiate pain control group did not consume opioids.
The change in opioid consumption from day 1 post-operative to day 14 post-operative in the opioid arm expressed in morphine milligram equivalents (MME).
Outcome measures
| Measure |
Standard of Care Group
n=43 Participants
Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure
Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control
|
Non-Opiate Pain Control Group
Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.
Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively
Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
Methocarbamol: 500 mg three times a week for 2 weeks postoperatively
|
|---|---|---|
|
Change in Opioid Consumption
Day 1 Post-Operatively
|
10.9 Morphine Milligram Equivalents (MME)
Standard Deviation 1.9
|
—
|
|
Change in Opioid Consumption
Day 14 Post-Operatively
|
0.1 Morphine Milligram Equivalents (MME)
Standard Deviation 1.9
|
—
|
Adverse Events
Standard of Care Group
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Non-Opiate Pain Control Group
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care Group
n=43 participants at risk
Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure
Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control
|
Non-Opiate Pain Control Group
n=43 participants at risk
Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.
Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively
Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
Methocarbamol: 500 mg three times a week for 2 weeks postoperatively
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
58.1%
25/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
41.9%
18/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
|
Gastrointestinal disorders
Nausea
|
44.2%
19/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
39.5%
17/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
|
Nervous system disorders
Light-headed/dizziness
|
41.9%
18/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
30.2%
13/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
|
General disorders
Break-through pain
|
30.2%
13/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
23.3%
10/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
14.0%
6/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
14.0%
6/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
|
Gastrointestinal disorders
Upset Stomach
|
4.7%
2/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
7.0%
3/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
7.0%
3/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
|
Eye disorders
Blurry Vision
|
9.3%
4/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
2.3%
1/43 • Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place