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Completed

NCT Number: NCT04169113

Opiate Prescribing Guidelines Following 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

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Key information

Conditions

Hip Injuries Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Group 1 - Opiate Tablets post Hip Arthroscopy

Other

Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.

Group 2 - Opiate Tablets post Hip Arthroscopy

Other

Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Opiates Taken

    Time frame: 24 hours post-operative

    Number of prescribed narcotic pills taken in the preceding time period

  7. Opiates Taken

    Time frame: 48 hours post-operative

    Number of prescribed narcotic medication tablets taken in the preceding time period

  8. Opiates Taken

    Time frame: 7 days post-operative

    Number of prescribed narcotic medication tablets taken in the preceding time period

  9. Opiates Taken

    Time frame: 21 days post-operative

    Number of prescribed narcotic medication tablets taken in the preceding time period

  10. Opiates Remaining

    Time frame: 24 hours post-operative

    Number of prescribed narcotic medication tablets remaining from initial amount prescribed

  11. Opiates Remaining

    Time frame: 48 hours post-operative

    Number of prescribed narcotic medication tablets remaining from initial amount prescribed

  12. Opiates Remaining

    Time frame: 7 days post-operative

    Number of prescribed narcotic medication tablets remaining from initial amount prescribed

  13. Opiates Remaining

    Time frame: 21 days post-operative

    Number of prescribed narcotic medication tablets remaining from initial amount prescribed

  14. Date of Last Opiate Taken

    Time frame: 21 days post-operative

    Days following surgery that the most recent dose of narcotic medication was taken

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2019
Registry last updated
Oct 5, 2020

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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