Clinical trial NCT04094701: Hip Arthroscopy Postoperative Opioid Demands
Official title: Randomized Control Trial Evaluating Postoperative Opioid Demands Following Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Pain
Femoral Acetabular Impingement
Labral Tear, Glenoid
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.
Primary purpose: TREATMENT

Brief summary: This study will be a prospective, single-blinded, randomized controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomized to one of the two treatment arms. The intervention group will receive 5 Norco pills, gabapentin (30 mg, once daily for 10 days following surgery), and Tylenol (1000 mg, three times daily for 10 days following surgery) while the control will receive the standard at our practice of 30 Norco pills.

Detailed description: Follow-up will take place at 1, 3, 6, and 12 months postoperatively. Variables of interest will include postoperative patient pain scores (i.e. Visual Analog Scale or VAS), total morphine equivalents taken in the first 30 days after discharge, number of unused opioid pills, opioid disposal rates, and standard patient reported outcomes measures (PROMs) including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), VAS for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS).

For the purpose of this study, the investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.

Timeline of Events:

1. Following informed consent during the office visit when surgery is scheduled, all patients will be randomized to one of the postoperative pain management protocols, either the control or opioid reduced.
2. Subjects will proceed with hip arthroscopy, including appropriate treatment and documentation of concomitant injuries.
3. Over the course of the 1st month postoperatively, patients will complete a 30-day diary detailing which medications they took on each day and their daily average pain level (indicating whether physical therapy was performed). Data pertaining to prescription refills (I.e., number of refills, time to refill), number of left over pain medications, and disposal rates of opioid medications will also be recorded at these time points as well.
4. Patients will return for standard of care postoperative visits at 1, 3, 6, and 12 months postoperatively. Patients will be asked to complete PROM questionnaires at the 3, 6, and 12 month follow-up time points

Eligibility criteria: Inclusion Criteria:

* Adult patients age 18-80 years
* English speaking
* Opioid naive patient (defined as not taking opioid pills within 6 weeks prior to surgery), confirmed by checking the Illinois Prescription monitoring program
* Primary hip arthroscopy
* Written and informed consent for study participation

Exclusion Criteria:

* Minors (\<18 years of age)
* Opioid tolerant patients
* Revision surgery
* Prior infections of the operative joint
* History of active malignancy within the past 5 years
* Chronic pain conditions including low back pain, chronic pain syndrome, fibromyalgia
* History of alcohol or other substance use disorder
* Other disease states including rheumatologic conditions, diabetes mellitus, hypo/hyperthyroidism, depression, anxiety
* Grade IV chondral defects

Primary outcomes:
measure: Pain Score
timeFrame: 1 month postoperatively
measure: Pain Score
timeFrame: 3 months postoperatively
measure: Pain Score
timeFrame: 6 months postoperatively
measure: Pain Score
timeFrame: 12 months postoperatively
measure: Total morphine equivalents taken
timeFrame: In the first 30 days after discharge
measure: Number of unused opioid pills
timeFrame: In the first 30 days after discharge
measure: Opioid disposal rates
timeFrame: In the first 30 days after discharge
Secondary outcomes:
measure: Hip disability and osteoarthritis outcome score
timeFrame: 1 month postoperatively
measure: Hip disability and osteoarthritis outcome score
timeFrame: 3 months postoperatively
measure: Hip disability and osteoarthritis outcome score
timeFrame: 6 months postoperatively
measure: Hip disability and osteoarthritis outcome score
timeFrame: 12 months postoperatively
measure: Harris Hip score
timeFrame: 1 month postoperatively
measure: Harris Hip score
timeFrame: 3 months postoperatively
measure: Harris Hip score
timeFrame: 6 months postoperatively
measure: Harris Hip score
timeFrame: 12 months postoperatively
measure: International hip outcome tool
timeFrame: 1 month postoperatively
measure: International hip outcome tool
timeFrame: 3 months postoperatively
measure: International hip outcome tool
timeFrame: 6 months postoperatively
measure: International hip outcome tool
timeFrame: 12 months postoperatively
measure: Hip outcome score
timeFrame: 1 month postoperatively
measure: Hip outcome score
timeFrame: 3 months postoperatively
measure: Hip outcome score
timeFrame: 6 months postoperatively
measure: Hip outcome score
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: