Opiate Prescribing Guidelines Following Hip Arthroscopy

NCT ID: NCT04169113

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2020-07-08

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.

Conditions

Hip Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1 - Hip Arthroscopy

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

Group Type: ACTIVE_COMPARATOR

Group 1 - Opiate Tablets post Hip Arthroscopy

Intervention Type: OTHER

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

Group 2 - Hip Arthroscopy

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

Group Type: ACTIVE_COMPARATOR

Group 2 - Opiate Tablets post Hip Arthroscopy

Intervention Type: OTHER

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

Interventions

Group 1 - Opiate Tablets post Hip Arthroscopy

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

Intervention Type: OTHER

Group 2 - Opiate Tablets post Hip Arthroscopy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Vehniah Tjong

Assistant Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University Department of Orthopaedic Surgery

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STU00207356

Identifier Type: -

Identifier Source: org_study_id