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NCT Number: NCT04094701

Hip Arthroscopy Postoperative Opioid Demands

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.

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Key information

Conditions

Opioid Use Femoracetabular Impingement Femoral Acetabular Impingement Joint Diseases Labral Tear, Glenoid Musculoskeletal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Carla M Edwards, PhD

CONTACT

[email protected]

312-563-5735

Jorge Chahla, MD, PhD

PRINCIPAL_INVESTIGATOR

Shane Nho, MD

SUB_INVESTIGATOR

About this study

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:

  • 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.
  • Subjects will proceed with hip arthroscopy, including appropriate treatment and documentation of concomitant injuries.
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent for study participation

Exclusion criteria

  • Minors (<18 years of age)
  • Opioid tolerant patients
  • Revision surgery
  • Prior infections of the operative joint
  • History of active malignancy 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

Treatment and study plan

Control Group Regimen

Other

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

Opioid reduced regimen

Other

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

Primary outcomes

  1. Pain Score

    Time frame: 1 month postoperatively

    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.

  2. Pain Score

    Time frame: 3 months postoperatively

    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.

  3. Pain Score

    Time frame: 6 months postoperatively

    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.

  4. Pain Score

    Time frame: 12 months postoperatively

    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.

  5. Total morphine equivalents taken

    Time frame: In the first 30 days after discharge

    Standardized reporting of amount of opioids taken

  6. Number of unused opioid pills

    Time frame: In the first 30 days after discharge

    Pills not taken by patient

  7. Opioid disposal rates

    Time frame: In the first 30 days after discharge

    Number of unused pills properly disposed of

Secondary outcomes

  1. Hip disability and osteoarthritis outcome score

    Time frame: 1 month postoperatively

    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.

  2. Hip disability and osteoarthritis outcome score

    Time frame: 3 months postoperatively

    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.

  3. Hip disability and osteoarthritis outcome score

    Time frame: 6 months postoperatively

    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.

  4. Hip disability and osteoarthritis outcome score

    Time frame: 12 months postoperatively

    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.

  5. Harris Hip score

    Time frame: 1 month postoperatively

    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.

  6. Harris Hip score

    Time frame: 3 months postoperatively

    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.

  7. Harris Hip score

    Time frame: 6 months postoperatively

    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.

  8. Harris Hip score

    Time frame: 12 months postoperatively

    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.

  9. International hip outcome tool

    Time frame: 1 month postoperatively

    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.

  10. International hip outcome tool

    Time frame: 3 months postoperatively

    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.

  11. International hip outcome tool

    Time frame: 6 months postoperatively

    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.

  12. International hip outcome tool

    Time frame: 12 months postoperatively

    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.

  13. Hip outcome score

    Time frame: 1 month postoperatively

    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.

  14. Hip outcome score

    Time frame: 3 months postoperatively

    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.

  15. Hip outcome score

    Time frame: 6 months postoperatively

    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.

  16. Hip outcome score

    Time frame: 12 months postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carla M. Edwards

CONTACT

[email protected]

312-563-5735

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Randomized Control Trial Evaluating Postoperative Opioid Demands Following Hip Arthroscopy

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2019
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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