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Opiate Prescribing Guidelines Following Hip Arthroscopy

How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04169113
Enrollment
111
Registered
2019-11-19
Start date
2018-06-12
Completion date
2020-07-08
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Injuries

Keywords

Hip Arthroscopy, Opiate Use

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.

Interventions

OTHERGroup 1 - Opiate Tablets post Hip Arthroscopy

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

OTHERGroup 2 - Opiate Tablets post Hip Arthroscopy

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating Scale (NPRS) Pain ScoresBaseline (pre-operative)minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Opiates Taken24 hours post-operativeNumber of prescribed narcotic pills taken in the preceding time period
Opiates Remaining24 hours post-operativeNumber of prescribed narcotic medication tablets remaining from initial amount prescribed
Date of Last Opiate Taken21 days post-operativeDays following surgery that the most recent dose of narcotic medication was taken
Number of Participants Reporting Side Effects24 hours postoperativelyAs reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting

Countries

United States

Participant flow

Participants by arm

ArmCount
Group 1 - Hip Arthroscopy
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
52
Group 2 - Hip Arthroscopy
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
59
Total111

Baseline characteristics

CharacteristicGroup 1 - Hip ArthroscopyGroup 2 - Hip ArthroscopyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
52 Participants59 Participants111 Participants
Age, Continuous37.8 Years
STANDARD_DEVIATION 11.2
36.9 Years
STANDARD_DEVIATION 11.8
37.3 Years
STANDARD_DEVIATION 11.5
Are you an active smoker?
No
50 Participants57 Participants107 Participants
Are you an active smoker?
Yes
2 Participants2 Participants4 Participants
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/codone)?
No
51 Participants59 Participants110 Participants
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/codone)?
Yes
1 Participants0 Participants1 Participants
Body Mass Index26.2 kg/m2
STANDARD_DEVIATION 5.5
27.8 kg/m2
STANDARD_DEVIATION 6.1
27.1 kg/m2
STANDARD_DEVIATION 5.9
Do you have a family history of substance abuse (ex. prescription or illicit drugs, alcohol)?
No
43 Participants51 Participants94 Participants
Do you have a family history of substance abuse (ex. prescription or illicit drugs, alcohol)?
Yes
9 Participants8 Participants17 Participants
Do you have a personal history of illicit substance abuse?
No
51 Participants59 Participants110 Participants
Do you have a personal history of illicit substance abuse?
Yes
1 Participants0 Participants1 Participants
If no, have you ever consistently smoked cigarettes (daily for > 1 month)?
No
46 Participants49 Participants95 Participants
If no, have you ever consistently smoked cigarettes (daily for > 1 month)?
Yes
6 Participants10 Participants16 Participants
Is this injury part of a workers compensation claim?
No
51 Participants58 Participants109 Participants
Is this injury part of a workers compensation claim?
Yes
1 Participants1 Participants2 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
38 Participants35 Participants73 Participants
Sex: Female, Male
Male
14 Participants24 Participants38 Participants
What is the highest level of education you attained?
Completed High School
5 Participants12 Participants17 Participants
What is the highest level of education you attained?
Graduate
16 Participants17 Participants33 Participants
What is the highest level of education you attained?
Undergraduate
31 Participants30 Participants61 Participants
What is your average yearly household income?
$100,000 -$149,999
11 Participants8 Participants19 Participants
What is your average yearly household income?
$150,000 - $199,999
6 Participants10 Participants16 Participants
What is your average yearly household income?
$200,000 or more
12 Participants12 Participants24 Participants
What is your average yearly household income?
$20,000 -$34,999
1 Participants3 Participants4 Participants
What is your average yearly household income?
$35,000 -$49,999
4 Participants5 Participants9 Participants
What is your average yearly household income?
$50,000 -$74,999
5 Participants8 Participants13 Participants
What is your average yearly household income?
$75,000 - $99,999
8 Participants10 Participants18 Participants
What is your average yearly household income?
Less than $20,000
4 Participants3 Participants7 Participants
What is your average yearly household income?
missing
1 Participants0 Participants1 Participants
What is your employment status?
Disabled
2 Participants0 Participants2 Participants
What is your employment status?
Employed
39 Participants48 Participants87 Participants
What is your employment status?
Unemployed
11 Participants11 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 59
other
Total, other adverse events
0 / 520 / 59
serious
Total, serious adverse events
0 / 520 / 59

Outcome results

Primary

Date of Last Opiate Taken

Days following surgery that the most recent dose of narcotic medication was taken

Time frame: 21 days post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyDate of Last Opiate Taken5.0 daysStandard Deviation 4.9
Group 2 (30) - Hip ArthroscopyDate of Last Opiate Taken4.6 daysStandard Deviation 5.8
Primary

Number of Participants Reporting Side Effects

As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting

Time frame: 24 hours postoperatively

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes16 Participants
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo31 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes18 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo35 Participants
Primary

Number of Participants Reporting Side Effects

As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting

Time frame: 21 days postoperatively

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes9 Participants
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo38 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes7 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo46 Participants
Primary

Number of Participants Reporting Side Effects

As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting

Time frame: 7 days postoperatively

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes10 Participants
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo37 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes8 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo45 Participants
Primary

Number of Participants Reporting Side Effects

As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting

Time frame: 48 hours postoperatively

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes15 Participants
Group 1 (60) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo32 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsYes14 Participants
Group 2 (30) - Hip ArthroscopyNumber of Participants Reporting Side EffectsNo39 Participants
Primary

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

Time frame: 24 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores3.9 score on a scaleStandard Deviation 2.5
Group 2 (30) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores3.8 score on a scaleStandard Deviation 2.3
Primary

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

Time frame: Baseline (pre-operative)

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores4.2 score on a scaleStandard Deviation 2.6
Group 2 (30) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores4.0 score on a scaleStandard Deviation 1.7
Primary

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

Time frame: 2 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores5.0 score on a scaleStandard Deviation 2.1
Group 2 (30) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores4.7 score on a scaleStandard Deviation 2.1
Primary

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

Time frame: 48 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores3.2 score on a scaleStandard Deviation 2.4
Group 2 (30) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores3.3 score on a scaleStandard Deviation 2.1
Primary

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

Time frame: 7 days post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores2.3 score on a scaleStandard Deviation 2.4
Group 2 (30) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores2.2 score on a scaleStandard Deviation 1.6
Primary

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

Time frame: 21 days

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores2.6 score on a scaleStandard Deviation 2.3
Group 2 (30) - Hip ArthroscopyNumeric Pain Rating Scale (NPRS) Pain Scores2.0 score on a scaleStandard Deviation 1.8
Primary

Opiates Remaining

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Time frame: 7 days post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Remaining49.6 tabletsStandard Deviation 15.9
Group 2 (30) - Hip ArthroscopyOpiates Remaining22.3 tabletsStandard Deviation 8.4
Primary

Opiates Remaining

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Time frame: 48 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Remaining54.8 tabletsStandard Deviation 5.7
Group 2 (30) - Hip ArthroscopyOpiates Remaining25.1 tabletsStandard Deviation 5.9
Primary

Opiates Remaining

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Time frame: 21 days post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Remaining49.5 tabletsStandard Deviation 16.5
Group 2 (30) - Hip ArthroscopyOpiates Remaining22.0 tabletsStandard Deviation 7.9
Primary

Opiates Remaining

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Time frame: 24 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Remaining57.0 tabletsStandard Deviation 2.2
Group 2 (30) - Hip ArthroscopyOpiates Remaining27.6 tabletsStandard Deviation 2.5
Primary

Opiates Taken

Number of prescribed narcotic medication tablets taken in the preceding time period

Time frame: 7 days post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Taken10.4 tabletsStandard Deviation 15.9
Group 2 (30) - Hip ArthroscopyOpiates Taken8.8 tabletsStandard Deviation 9.3
Primary

Opiates Taken

Number of prescribed narcotic pills taken in the preceding time period

Time frame: 24 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Taken3.0 tabletsStandard Deviation 2.2
Group 2 (30) - Hip ArthroscopyOpiates Taken2.4 tabletsStandard Deviation 2.5
Primary

Opiates Taken

Number of prescribed narcotic medication tablets taken in the preceding time period

Time frame: 48 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Taken5.2 tabletsStandard Deviation 5.7
Group 2 (30) - Hip ArthroscopyOpiates Taken4.9 tabletsStandard Deviation 5.9
Primary

Opiates Taken

Number of prescribed narcotic medication tablets taken in the preceding time period

Time frame: 21 days post-operative

ArmMeasureValue (MEAN)Dispersion
Group 1 (60) - Hip ArthroscopyOpiates Taken10.5 tabletsStandard Deviation 16.5
Group 2 (30) - Hip ArthroscopyOpiates Taken9.2 tabletsStandard Deviation 11.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026