Clinical trial NCT04169113: Opiate Prescribing Guidelines Following Hip Arthroscopy
Official title: How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Injuries
Keywords: Hip Arthroscopy
Opiate Use
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: Baseline (pre-operative)
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: 2 hours post-operative
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: 24 hours post-operative
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: 48 hours post-operative
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: 7 days post-operative
measure: Opiates Taken
timeFrame: 24 hours post-operative
measure: Opiates Taken
timeFrame: 48 hours post-operative
measure: Opiates Taken
timeFrame: 7 days post-operative
measure: Opiates Taken
timeFrame: 21 days post-operative
measure: Opiates Remaining
timeFrame: 24 hours post-operative
measure: Opiates Remaining
timeFrame: 48 hours post-operative
measure: Opiates Remaining
timeFrame: 7 days post-operative
measure: Opiates Remaining
timeFrame: 21 days post-operative
measure: Date of Last Opiate Taken
timeFrame: 21 days post-operative
measure: Numeric Pain Rating Scale (NPRS) Pain Scores
timeFrame: 21 days
measure: Number of Participants Reporting Side Effects
timeFrame: 24 hours postoperatively
measure: Number of Participants Reporting Side Effects
timeFrame: 48 hours postoperatively
measure: Number of Participants Reporting Side Effects
timeFrame: 7 days postoperatively
measure: Number of Participants Reporting Side Effects
timeFrame: 21 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Orthopaedic Surgery
state: Illinois
Study officials:
References: