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

NCT ID: NCT01658072

Last Updated: 2022-04-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Peri-Articular Injection

Group Type EXPERIMENTAL

Peri-Articular Injection

Intervention Type PROCEDURE

Use of a different analgesic protocol, based on a peri-articular injection

Epidural Patient Controlled Analgesia (Epidural PCA)

Group Type ACTIVE_COMPARATOR

Epidural Patient Controlled Analgesia (Epidural PCA)

Intervention Type PROCEDURE

Epidural analgesia pathway.

Interventions

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Peri-Articular Injection

Use of a different analgesic protocol, based on a peri-articular injection

Intervention Type PROCEDURE

Epidural Patient Controlled Analgesia (Epidural PCA)

Epidural analgesia pathway.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kethy M Jules-Elysee, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2012-053

Identifier Type: -

Identifier Source: org_study_id

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