Hip ArthroscopyPhase 4NCT05076110
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
A Phase 4 study testing Oxycodone, Ibuprofen and Gabapentin in people with Hip Arthroscopy, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hip Arthroscopy
- What is being tested?
- Oxycodone, Ibuprofen and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2022to 25 Oct 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)
Who cannot join
- medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
- Substantial alcohol or drug abuse.
- History of narcotics within 6 months of surgery.
- Pregnancy.
- Renal impairment.
- Peptic ulcer disease.
- GI bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.
- Conditions
- Hip Arthroscopy
- Being tested
- Oxycodone, Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
5 mg tablets every 4 hours postoperatively as needed for pain control
IbuprofenDrug
800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
GabapentinDrug
300 mg three times a day for 5 days then wean off by day 10 postoperatively
AcetaminophenDrug
1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
MethocarbamolDrug
Also called Robaxin
500 mg three times a week for 2 weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Active comparator | Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure Receives: Drug: Oxycodone |
| Non-Opiate Pain Control Group | Experimental | Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure. Receives: Drug: Ibuprofen; Drug: Gabapentin; Drug: Acetaminophen; Drug: Methocarbamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
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.
Measured: 1 day post-operatively, 14 days post-operatively
Secondary outcomes (2)
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
The 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.
Measured: Baseline; 14 days post operatively
Change in Opioid Consumption
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).
Measured: Day 1 Post-Operatively; Day 14 Post-Operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start7 Apr 2022
- Primary completion25 Oct 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip ArthroscopyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelechi Okoroha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076110
- Sponsor's protocol ID
- 21-003441
- Status last verified
- May 2026
- First submitted
- 29 Sep 2021
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
- ClinicalTrials.gov ID
- NCT05076110
- Acronym / sponsor ID
- 21-003441
- Conditions
- Hip Arthroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | Active comparator | Drug: OxycodoneSubjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure |
| Non-Opiate Pain Control Group | Experimental | Drug: Ibuprofen, Drug: Gabapentin, Drug: Acetaminophen, Drug: MethocarbamolSubjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)
Key exclusion criteria (7 listed)
- medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
- Substantial alcohol or drug abuse.
- History of narcotics within 6 months of surgery.
- Pregnancy.
- Renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone5 mg tablets every 4 hours postoperatively as needed for pain control | Drug | Standard of Care Group |
| Ibuprofen800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day | Drug | Non-Opiate Pain Control Group |
| Gabapentin300 mg three times a day for 5 days then wean off by day 10 postoperatively | Drug | Non-Opiate Pain Control Group |
| Acetaminophen1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day | Drug | Non-Opiate Pain Control Group |
| MethocarbamolAlso: Robaxin500 mg three times a week for 2 weeks postoperatively | Drug | Non-Opiate Pain Control Group |
Primary outcome
Change in Pain Score
Time frame: 1 day post-operatively, 14 days post-operatively
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.
2 secondary outcomes
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Time frame: Baseline; 14 days post operatively
Change in Opioid Consumption
Time frame: Day 1 Post-Operatively; Day 14 Post-Operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hip Arthroscopy
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
RecruitingPhase 2
Painful Post-Operative Hip Study
Unilateral Hip Arthroscopy
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelechi Okoroha, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone, Ibuprofen and Gabapentin in people with Hip Arthroscopy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score (time frame: 1 day post-operatively, 14 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.