Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05076110

Collaborator

(none)

188

Enrollment

Location

Arms

11.8

Anticipated Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthroscopy	Drug: Oxycodone Drug: Ibuprofen Drug: Gabapentin Drug: Acetaminophen Drug: Methocarbamol	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Actual Study Start Date :

Apr 7, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Group Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure	Drug: Oxycodone 5 mg tablets every 4 hours postoperatively as needed for pain control
Experimental: Non-Opiate Pain Control Group Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.	Drug: Ibuprofen 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day Drug: Gabapentin 300 mg three times a day for 5 days then wean off by day 10 postoperatively Drug: Acetaminophen 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day Drug: Methocarbamol 500 mg three times a week for 2 weeks postoperatively Other Names: Robaxin

Arm

Intervention/Treatment

Active Comparator: Standard of Care Group

Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure

Drug: Oxycodone

5 mg tablets every 4 hours postoperatively as needed for pain control

Experimental: Non-Opiate Pain Control Group

Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.

Drug: Ibuprofen

800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day

Drug: Gabapentin

300 mg three times a day for 5 days then wean off by day 10 postoperatively

Drug: Acetaminophen

1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day

Drug: Methocarbamol

500 mg three times a week for 2 weeks postoperatively

Other Names:

Robaxin

Outcome Measures

Primary Outcome Measures

Change in pain score [Baseline, 14 days post-operatively]
Measure using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)

Exclusion Criteria:

medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
Substantial alcohol or drug abuse.
History of narcotics within 6 months of surgery.
Pregnancy.
Renal impairment.
Peptic ulcer disease.
GI bleeding.