Hip InjuriesNCT04169113
Opiate Prescribing Guidelines Following Hip Arthroscopy
A study testing Group 1 - Opiate Tablets post Hip Arthroscopy and Group 2 - Opiate Tablets post Hip Arthroscopy in people with Hip Injuries, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the study is to determine if opiates are required to achieve appropriate analgesia after hip arthroscopy in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Group 1 - Opiate Tablets post Hip Arthroscopy and Group 2 - Opiate Tablets post Hip Arthroscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 8 Jul 2020
- Phase
- Interventional
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
- 18 years old or greater
- Ability to read and speak English
Who cannot join
- Revision surgery
- Oncologic etiology
- Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening
- Patients with a current indication of narcotic use
- Individuals unable to provide informed consent:
- Prisoners
- Pregnant women
- Minors/Individuals under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Orthopaedic Surgery
Chicago, Illinois, 60611
About this study
Official title: How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?
The purpose of the study is to determine if opiates are required to achieve appropriate analgesia after hip arthroscopy in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic
Read the detailed description
Perioperative pain management is an important aspect of quality patient care. Opioid pain medications are increasingly being used for pain control, with the United States writing over 250 million prescriptions for painkillers per year. Increased usage has led to unintended negative consequences for individuals and society. It is estimated that 46 people die each day from an overdose of prescription painkillers, and individual use can lead to the development of tolerance and worse treatment outcomes. Further issues arise when opioids are misused, it is estimated that nontherapeutic use has increased three fold in recent years. In the United States alone in 2006 the estimated total cost of opioid prescription misuse was $53.4 billion, of which $42 billion was attributed to lost productivity, $8.2 billion to criminal justice cost and the remainder drug abuse treatment and medical complications. The federal government has recognized this epidemic and raised a call for clinicians to more responsibly prescribe opiate pain medications
Opiate use has increased in recent years, from 2000-2010 the use of opiates in office based visits nearly doubled from 11.3% to 19.6% whereas there was no change in the prescribing of non-opioid pharmacotherapies. Further, when specifically looking at new musculoskeletal pain visits, one half resulted in pharmacologic treatment, with the prescribing of non-opioid pharmacotherapies decreasing from 38% to 29% from 2000 to 2010, respectively. The clinical use of opioids for post-operative pain control has also been linked to the opioid epidemic and risk of future abuse. Legitimate opioid use before high school graduation is independently associated with a 33% increased risk of future misuse after high school.
It has been estimated that orthopedic surgeons prescribe 7.7% of all opioids in the United States.Special attention needs to be paid to the amount of opioid pain medications orthopedic surgeons prescribe to patients after ambulatory surgery, there is considerable variability among surgeon and procedure in regards to the amount of opioids to prescribe with many patients left with excess unused medication .An analysis of 250 patients undergoing outpatient upper extremity surgery found that on average patients consumed 10 opioid pills, with 19 pills left over and a total of 4,639 pills going unused in the cohort. Leftover prescription opioids are at risk for diversion to family and friends for nonmedical use. Further studies are needed to quantify the amount of opioids to prescribe for specific orthopedic procedures to limit excess narcotic use, misuse, diversion and contribution to the opioid epidemic.
- Conditions
- Hip Injuries
- Being tested
- Group 1 - Opiate Tablets post Hip Arthroscopy, Group 2 - Opiate Tablets post Hip Arthroscopy
- Keywords
- Hip Arthroscopy, Opiate Use
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 - Opiate Tablets post Hip ArthroscopyOther
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip ArthroscopyOther
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Hip Arthroscopy | Active comparator | Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. Receives: Other: Group 1 - Opiate Tablets post Hip Arthroscopy |
| Group 2 - Hip Arthroscopy | Active comparator | Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. Receives: Other: Group 2 - Opiate Tablets post Hip Arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Measured: Baseline (pre-operative)
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Measured: 2 hours post-operative
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Measured: 24 hours post-operative
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Measured: 48 hours post-operative
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Measured: 7 days post-operative
Opiates Taken
Number of prescribed narcotic pills taken in the preceding time period
Measured: 24 hours post-operative
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Measured: 48 hours post-operative
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Measured: 7 days post-operative
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Measured: 21 days post-operative
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Measured: 24 hours post-operative
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Measured: 48 hours post-operative
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Measured: 7 days post-operative
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Measured: 21 days post-operative
Date of Last Opiate Taken
Days following surgery that the most recent dose of narcotic medication was taken
Measured: 21 days post-operative
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Measured: 21 days
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting
Measured: 24 hours postoperatively
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Measured: 48 hours postoperatively
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Measured: 7 days postoperatively
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Measured: 21 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start12 Jun 2018
- Primary completion21 Feb 2020
- Study completion8 Jul 2020
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 InjuriesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vehniah Tjong, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169113
- Sponsor's protocol ID
- STU00207356
- Status last verified
- Sep 2020
- First submitted
- 13 Nov 2019
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?
- ClinicalTrials.gov ID
- NCT04169113
- Acronym / sponsor ID
- STU00207356
- Conditions
- Hip Injuries
- Keywords
- Hip Arthroscopy, Opiate Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 27 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if opiates are required to achieve appropriate analgesia after hip arthroscopy in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic
Detailed description
Perioperative pain management is an important aspect of quality patient care. Opioid pain medications are increasingly being used for pain control, with the United States writing over 250 million prescriptions for painkillers per year. Increased usage has led to unintended negative consequences for individuals and society. It is estimated that 46 people die each day from an overdose of prescription painkillers, and individual use can lead to the development of tolerance and worse treatment outcomes. Further issues arise when opioids are misused, it is estimated that nontherapeutic use has increased three fold in recent years. In the United States alone in 2006 the estimated total cost of opioid prescription misuse was $53.4 billion, of which $42 billion was attributed to lost productivity, $8.2 billion to criminal justice cost and the remainder drug abuse treatment and medical complications. The federal government has recognized this epidemic and raised a call for clinicians to more responsibly prescribe opiate pain medications
Opiate use has increased in recent years, from 2000-2010 the use of opiates in office based visits nearly doubled from 11.3% to 19.6% whereas there was no change in the prescribing of non-opioid pharmacotherapies. Further, when specifically looking at new musculoskeletal pain visits, one half resulted in pharmacologic treatment, with the prescribing of non-opioid pharmacotherapies decreasing from 38% to 29% from 2000 to 2010, respectively. The clinical use of opioids for post-operative pain control has also been linked to the opioid epidemic and risk of future abuse. Legitimate opioid use before high school graduation is independently associated with a 33% increased risk of future misuse after high school.
It has been estimated that orthopedic surgeons prescribe 7.7% of all opioids in the United States.Special attention needs to be paid to the amount of opioid pain medications orthopedic surgeons prescribe to patients after ambulatory surgery, there is considerable variability among surgeon and procedure in regards to the amount of opioids to prescribe with many patients left with excess unused medication .An analysis of 250 patients undergoing outpatient upper extremity surgery found that on average patients consumed 10 opioid pills, with 19 pills left over and a total of 4,639 pills going unused in the cohort. Leftover prescription opioids are at risk for diversion to family and friends for nonmedical use. Further studies are needed to quantify the amount of opioids to prescribe for specific orthopedic procedures to limit excess narcotic use, misuse, diversion and contribution to the opioid epidemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Hip Arthroscopy | Active comparator | Other: Group 1 - Opiate Tablets post Hip ArthroscopyWill be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. |
| Group 2 - Hip Arthroscopy | Active comparator | Other: Group 2 - Opiate Tablets post Hip ArthroscopyWill be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
- 18 years old or greater
- Ability to read and speak English
Key exclusion criteria (8 listed)
- Revision surgery
- Oncologic etiology
- Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening
- Patients with a current indication of narcotic use
- Individuals unable to provide informed consent:
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 |
|---|---|---|
| Group 1 - Opiate Tablets post Hip ArthroscopyWill be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. | Other | Group 1 - Hip Arthroscopy |
| Group 2 - Opiate Tablets post Hip ArthroscopyWill be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. | Other | Group 2 - Hip Arthroscopy |
Primary outcome
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: Baseline (pre-operative)
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: 2 hours post-operative
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: 24 hours post-operative
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: 48 hours post-operative
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: 7 days post-operative
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Opiates Taken
Time frame: 24 hours post-operative
Number of prescribed narcotic pills taken in the preceding time period
Opiates Taken
Time frame: 48 hours post-operative
Number of prescribed narcotic medication tablets taken in the preceding time period
Opiates Taken
Time frame: 7 days post-operative
Number of prescribed narcotic medication tablets taken in the preceding time period
Opiates Taken
Time frame: 21 days post-operative
Number of prescribed narcotic medication tablets taken in the preceding time period
Opiates Remaining
Time frame: 24 hours post-operative
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Opiates Remaining
Time frame: 48 hours post-operative
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Opiates Remaining
Time frame: 7 days post-operative
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Opiates Remaining
Time frame: 21 days post-operative
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Date of Last Opiate Taken
Time frame: 21 days post-operative
Days following surgery that the most recent dose of narcotic medication was taken
Numeric Pain Rating Scale (NPRS) Pain Scores
Time frame: 21 days
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Number of Participants Reporting Side Effects
Time frame: 24 hours postoperatively
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting
Number of Participants Reporting Side Effects
Time frame: 48 hours postoperatively
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Number of Participants Reporting Side Effects
Time frame: 7 days postoperatively
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Number of Participants Reporting Side Effects
Time frame: 21 days postoperatively
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 - Opiate Tablets post Hip Arthroscopy and Group 2 - Opiate Tablets post Hip Arthroscopy in people with Hip Injuries, run by Northwestern University 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 3 inclusion and 8 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 5 Oct 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2020). 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?
Numeric Pain Rating Scale (NPRS) Pain Scores (time frame: Baseline (pre-operative)). The study lists 19 primary outcomes in all. 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 5 Oct 2020.