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Opiate Prescribing Guidelines Following Hip Arthroscopy

Primary Purpose

Hip Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1 - Opiate Tablets post Hip Arthroscopy
Group 2 - Opiate Tablets post Hip Arthroscopy
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Injuries focused on measuring Hip Arthroscopy, Opiate Use

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Department of Orthopaedic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1 - Hip Arthroscopy

Group 2 - Hip Arthroscopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
Opiates Taken
Number of prescribed narcotic pills taken in the preceding time period
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Date of Last Opiate Taken
Days following surgery that the most recent dose of narcotic medication was taken
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
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting

Secondary Outcome Measures

Full Information

First Posted
November 13, 2019
Last Updated
September 9, 2020
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04169113
Brief Title
Opiate Prescribing Guidelines Following Hip Arthroscopy
Official Title
How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Injuries
Keywords
Hip Arthroscopy, Opiate Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Hip Arthroscopy
Arm Type
Active Comparator
Arm Description
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Arm Title
Group 2 - Hip Arthroscopy
Arm Type
Active Comparator
Arm Description
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Intervention Type
Other
Intervention Name(s)
Group 1 - Opiate Tablets post Hip Arthroscopy
Intervention Description
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Intervention Type
Other
Intervention Name(s)
Group 2 - Opiate Tablets post Hip Arthroscopy
Intervention Description
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time Frame
Baseline (pre-operative)
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time Frame
2 hours post-operative
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time Frame
24 hours post-operative
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time Frame
48 hours post-operative
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time Frame
7 days post-operative
Title
Opiates Taken
Description
Number of prescribed narcotic pills taken in the preceding time period
Time Frame
24 hours post-operative
Title
Opiates Taken
Description
Number of prescribed narcotic medication tablets taken in the preceding time period
Time Frame
48 hours post-operative
Title
Opiates Taken
Description
Number of prescribed narcotic medication tablets taken in the preceding time period
Time Frame
7 days post-operative
Title
Opiates Taken
Description
Number of prescribed narcotic medication tablets taken in the preceding time period
Time Frame
21 days post-operative
Title
Opiates Remaining
Description
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time Frame
24 hours post-operative
Title
Opiates Remaining
Description
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time Frame
48 hours post-operative
Title
Opiates Remaining
Description
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time Frame
7 days post-operative
Title
Opiates Remaining
Description
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time Frame
21 days post-operative
Title
Date of Last Opiate Taken
Description
Days following surgery that the most recent dose of narcotic medication was taken
Time Frame
21 days post-operative
Title
Numeric Pain Rating Scale (NPRS) Pain Scores
Description
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time Frame
21 days
Title
Number of Participants Reporting Side Effects
Description
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting
Time Frame
24 hours postoperatively
Title
Number of Participants Reporting Side Effects
Description
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Time Frame
48 hours postoperatively
Title
Number of Participants Reporting Side Effects
Description
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Time Frame
7 days postoperatively
Title
Number of Participants Reporting Side Effects
Description
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Time Frame
21 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwestern University Department of Orthopaedic Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Opiate Prescribing Guidelines Following Hip Arthroscopy

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