Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia (PCA)

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Epidural Patient Controlled Analgesia (Epidural PCA); Procedure: Peri-Articular Injection

• Registration Number: NCT01658072
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

The best way to provide analgesia after total hip arthroplasty is hotly debated. There are two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their proponents, but there are limited data for making an informed choice of protocols. For total hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with physical therapy. However, epidural analgesia can be associated with nausea, pruritis, dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided to use a different analgesic protocol, based on a peri-articular injection. This protocol avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as part of a multimodal pain therapy. The investigators propose to compare peri-articular injection to epidural patient controlled analgesia (Epidural PCA). The investigators will enroll 90 total patients (45 per study arm). The enrollment period will be approximately one year and the duration of the follow-up with study patients will be three months following their procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-06
• Primary Completion: 2013-05
• Results First Submitted: 2016-04-04
• Results First Submitted QC: 2016-04-04
• Results First Posted: 2016-05-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
• Age 50 to 80 years old
• Planned use of regional anesthesia
• Ability to follow study protocol

Exclusion Criteria

• Patients younger than 50 years old and older than 80
• Patients intending to receive general anesthesia
• Allergy or intolerance to one of the study medications
• Patients with an ASA of IV
• Patients with insulin-dependent diabetes
• Patients with hepatic (liver) failure
• Patients with chronic renal (kidney) failure
• Chronic opioid use (taking opioids for longer than 3 months)
• Patients with any prior major ipsilateral hip surgery
• Allergy to any of the medications (or adhesives) involved in the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Patient Controlled Analgesia (Epidural PCA)	Epidural Patient Controlled Analgesia (Epidural PCA)	-
Peri-Articular Injection	Peri-Articular Injection	-

Primary Outcome Measures

Name	Time	Method
Time Until Patient is Ready for Discharge	Length of Hospital Stay, an expected average of 3 days	"readiness for discharge" to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States