NCT04169113

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

August 27, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

November 13, 2019

Results QC Date

July 29, 2020

Last Update Submit

September 9, 2020

Conditions

Hip Injuries

Keywords

Hip ArthroscopyOpiate Use

Outcome Measures

Primary Outcomes (19)

  • 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

Study Arms (2)

Group 1 - Hip Arthroscopy

ACTIVE COMPARATOR

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

Other: Group 1 - Opiate Tablets post Hip Arthroscopy

Group 2 - Hip Arthroscopy

ACTIVE COMPARATOR

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

Other: Group 2 - Opiate Tablets post Hip Arthroscopy

Interventions

Group 1 - Opiate Tablets post Hip ArthroscopyOTHER

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

Group 1 - Hip Arthroscopy
Group 2 - Opiate Tablets post Hip ArthroscopyOTHER

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

Group 2 - Hip Arthroscopy

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
  • years old or greater
  • Ability to read and speak English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Melissa Shauver; Research Project Manager
Organization
Northwestern University
melissa.shauver1@nm.org
3124726024

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 19, 2019

Study Start

June 12, 2018

Primary Completion

February 21, 2020

Study Completion

July 8, 2020

Last Updated

October 5, 2020

Results First Posted

August 27, 2020

Record last verified: 2020-09

Locations

US(1)