Opioid-free Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2023-12-01

Brief Summary

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The primary objective of investigators' proposed study is to demonstrate that the following two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS) scores up to 3 months post-operatively: one that is administered a modified multimodal analgesic pathway without opioids and the other administered the current standard multimodal analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The secondary objective is to demonstrate that these cohorts will also have equivalent functional outcomes as determined by both objective measures (such as hip range of motion) and patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.

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Detailed Description

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard multimodal analgesic pathway with opioids

This is the control group, who will receive the current standard multimodal analgesic regimen, which includes opioids following total hip arthroplasty at Johns Hopkins Bayview Hospital.

The current standard multimodal analgesic regimen utilizes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Opioid (fentanyl) \& Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: 0.25 % bupivacaine with epinephrine and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Oxycodone 5-10 mg PO, IV opioids (Morphine, hydromorphone), Acetaminophen 1000 mg PO q6hr

Group Type NO_INTERVENTION

No interventions assigned to this group

Modified multimodal analgesic pathway without opioids

This is the experimental group, who will receive a modified multimodal analgesic regimen, which excludes the use of any opioids.

The modified multimodal analgesic regimen utilizes the following medications:

includes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: Liposomal bupivacaine, 0.25 % bupivacaine with epinephrine, Betamethasone sodium phosphate, betamethasone acetate and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Ketamine IV, Ketorolac 15 mg PO, Acetaminophen 1000 mg PO q6hr

Group Type EXPERIMENTAL

Exclusion of opioid analgesics

Intervention Type OTHER

The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.

Interventions

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Exclusion of opioid analgesics

The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients of all ages with end-stage primary hip osteoarthritis.

Exclusion Criteria

* Patients with creatinine clearance between 30 and 60 mL/min
* Use of any opioid analgesics in the 6 months preceding surgery
* Revision total hip arthroplasty
* Patients with liver insufficiency
* Patients on chronic anticoagulation
* Workers compensation patients
* Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)

Eligible Sex

ALL

Accepts Healthy Volunteers

No