ClinicalTrials.gg
RecruitingNCT04094701Updated Aug 13, 2026

Hip Arthroscopy Postoperative Opioid Demands

An interventional study of Control Group Regimen and Opioid reduced regimen in Opioid Use, Pain and Femoral Acetabular Impingement, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,880 studies in Pain with a site in United States — 315 open to participants now, 394 under way, 24 of them phase 3. Pain · United States.

Planned enrollment
569th of 2,558
170 · median 66
Started
2020
with 100 others
No phase
1,241 of 2,880
183 open now
Primary completion
2027-11
later than 259 of 393 live
Registered
2,031st of 2,880
by date

Among the 2,880 studies in Pain with a site in United States, this one is the 569th largest by planned enrollment of the 2,558 interventional ones, is one of 101 that started in 2020, is one of 1,241 with no phase, reaches primary completion later than 259 of the 393 other live ones, and was the 2,031st registered.

By phase

2,880 studies; the count open now beside each. This study's row is marked.

No phasethis study1,241 · 183 open
Phase 4372 · 22 open
Phase 3342 · 18 open
Phase 2340 · 24 open
Observational300 · 35 open
Phase 1206 · 29 open
Phase 1/243 · 2 open
Phase 2/332 · 2 open
Other kind4 · 0 open

By the year they started

First in 1957; this study’s year is marked. 101 started in 2020.

Size and results

Median enrollment 66 across the 2,558 interventional studies, 99 across the 299 observational. Of the 2,223 that completed or were terminated, 1,051 (47%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 2,880 studies in Pain with a site in United States, or all of them as a file.
02

Study summary

This study will be a prospective, single-blinded, randomized controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomized to one of the two treatment arms. The intervention group will receive 5 Norco pills, gabapentin (30 mg, once daily for 10 days following surgery), and Tylenol (1000 mg, three times daily for 10 days following surgery) while the control will receive the standard at our practice of 30 Norco pills.

Read the detailed description

Follow-up will take place at 1, 3, 6, and 12 months postoperatively. Variables of interest will include postoperative patient pain scores (i.e. Visual Analog Scale or VAS), total morphine equivalents taken in the first 30 days after discharge, number of unused opioid pills, opioid disposal rates, and standard patient reported outcomes measures (PROMs) including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), VAS for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS).

For the purpose of this study, the investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.

Timeline of Events:

  1. Following informed consent during the office visit when surgery is scheduled, all patients will be randomized to one of the postoperative pain management protocols, either the control or opioid reduced.
  2. Subjects will proceed with hip arthroscopy, including appropriate treatment and documentation of concomitant injuries.
  3. Over the course of the 1st month postoperatively, patients will complete a 30-day diary detailing which medications they took on each day and their daily average pain level (indicating whether physical therapy was performed). Data pertaining to prescription refills (I.e., number of refills, time to refill), number of left over pain medications, and disposal rates of opioid medications will also be recorded at these time points as well.
  4. Patients will return for standard of care postoperative visits at 1, 3, 6, and 12 months postoperatively. Patients will be asked to complete PROM questionnaires at the 3, 6, and 12 month follow-up time points
03

Conditions studied

  • Opioid Use
  • Pain
  • Femoral Acetabular Impingement
  • Labral Tear, Glenoid
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients age 18-80 years
  • English speaking
  • Opioid naive patient (defined as not taking opioid pills within 6 weeks prior to surgery), confirmed by checking the Illinois Prescription monitoring program
  • Primary hip arthroscopy
  • Written and for study participation

Exclusion criteria

Exclusion Criteria:

  • Minors (\<18 years of age)
  • Opioid tolerant patients
  • Revision surgery
  • Prior infections of the operative joint
  • History of active within the past 5 years
  • Chronic pain conditions including low back pain, chronic pain syndrome, fibromyalgia
  • History of alcohol or other substance use disorder
  • Other disease states including rheumatologic conditions, diabetes mellitus, hypo/hyperthyroidism, depression, anxiety
  • Grade IV chondral defects
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
170 participants (estimated)

Study arms

  • Placebo comparator
    Control Group

    Control Group will receive the following pain medication regimen: \- Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

    Other: Control Group Regimen

  • Experimental
    Experimental Group - Opioid Reduced

    Experimental - opioid reduced: 50% less oxycodone relative to control group * Tylenol extra strength (1000 mg, three times daily for 10 days following surgery) * Gabapentin (300 mg at night for 10 days following surgery) * Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

    Other: Opioid reduced regimen

Interventions

  • OtherControl Group Regimen

    Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills. This is the standard of care prescribing procedure for pain management after hip arthroscopy.

  • OtherOpioid reduced regimen

    Tylenol extra strength (1000 mg, three times daily for 10 days following surgery), Gabapentin (300 mg at night for 10 days following surgery) and Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills

06

What researchers measure

Primary outcomes

  1. Pain Score

    Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Time frame: 1 month postoperatively

  2. Pain Score

    Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Time frame: 3 months postoperatively

  3. Pain Score

    Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Time frame: 6 months postoperatively

  4. Pain Score

    Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Time frame: 12 months postoperatively

  5. Total morphine equivalents taken

    Standardized reporting of amount of opioids taken

    Time frame: In the first 30 days after discharge

  6. Number of unused opioid pills

    Pills not taken by patient

    Time frame: In the first 30 days after discharge

  7. Opioid disposal rates

    Number of unused pills properly disposed of

    Time frame: In the first 30 days after discharge

Secondary outcomes

  1. Hip disability and osteoarthritis outcome score

    assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.

    Time frame: 1 month postoperatively

  2. Hip disability and osteoarthritis outcome score

    assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.

    Time frame: 3 months postoperatively

  3. Hip disability and osteoarthritis outcome score

    assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.

    Time frame: 6 months postoperatively

  4. Hip disability and osteoarthritis outcome score

    assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.

    Time frame: 12 months postoperatively

  5. Harris Hip score

    gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.

    Time frame: 1 month postoperatively

  6. Harris Hip score

    gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.

    Time frame: 3 months postoperatively

  7. Harris Hip score

    gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.

    Time frame: 6 months postoperatively

  8. Harris Hip score

    gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.

    Time frame: 12 months postoperatively

  9. International hip outcome tool

    comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters.

    Time frame: 1 month postoperatively

  10. International hip outcome tool

    comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters.

    Time frame: 3 months postoperatively

  11. International hip outcome tool

    comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters.

    Time frame: 6 months postoperatively

  12. International hip outcome tool

    comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters.

    Time frame: 12 months postoperatively

  13. Hip outcome score

    questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function.

    Time frame: 1 month postoperatively

  14. Hip outcome score

    questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function.

    Time frame: 3 months postoperatively

  15. Hip outcome score

    questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function.

    Time frame: 6 months postoperatively

  16. Hip outcome score

    questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function.

    Time frame: 12 months postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2020 (actual). Primary completion is estimated for Nov 2027, 85 months after the start.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 85 months is above that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2019
First posted
Sep 19, 2019
StartActual
Oct 21, 2020
Primary completionEst.
Nov 2027
CompletionEst.
Mar 2028
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04094701
Responsible party
Sponsor
First posted
Sep 19, 2019
Start date
Oct 21, 2020
Primary completion
Nov 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Carla M. Edwards
Contact
carla_edwards@rush.edu
312-563-5735

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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