Opiate Prescribing Guidelines Following Hip Arthroscopy

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

Study Overview

• Status: Completed
• Conditions: Hip Injuries
• Intervention / Treatment: Other: Group 1 - Opiate Tablets post Hip Arthroscopy; Other: Group 2 - Opiate Tablets post Hip Arthroscopy

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 Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Orthopaedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 - Hip Arthroscopy; Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.	Other: Group 1 - Opiate Tablets post Hip Arthroscopy; Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Active Comparator: Group 2 - Hip Arthroscopy; Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.	Other: Group 2 - Opiate Tablets post Hip Arthroscopy; Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	7 days post-operative
Opiates Taken	Number of prescribed narcotic pills taken in the preceding time period	24 hours post-operative
Opiates Taken	Number of prescribed narcotic medication tablets taken in the preceding time period	48 hours post-operative
Opiates Taken	Number of prescribed narcotic medication tablets taken in the preceding time period	7 days post-operative
Opiates Taken	Number of prescribed narcotic medication tablets taken in the preceding time period	21 days post-operative
Opiates Remaining	Number of prescribed narcotic medication tablets remaining from initial amount prescribed	24 hours post-operative
Opiates Remaining	Number of prescribed narcotic medication tablets remaining from initial amount prescribed	48 hours post-operative
Opiates Remaining	Number of prescribed narcotic medication tablets remaining from initial amount prescribed	7 days post-operative
Opiates Remaining	Number of prescribed narcotic medication tablets remaining from initial amount prescribed	21 days post-operative
Date of Last Opiate Taken	Days following surgery that the most recent dose of narcotic medication was taken	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	21 days
Number of Participants Reporting Side Effects	As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting	24 hours postoperatively
Number of Participants Reporting Side Effects	As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting	48 hours postoperatively
Number of Participants Reporting Side Effects	As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting	7 days postoperatively
Number of Participants Reporting Side Effects	As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting	21 days postoperatively

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): July 8, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Hip Arthroscopy; Opiate Use
• Additional Relevant MeSH Terms: Wounds and Injuries; Hip Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Opiate Alkaloids
• Other Study ID Numbers: STU00207356

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No