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

NCT01658072 | Completed Results DMC

• 1 other identifier: 2012-053
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Total Hip Arthroplasty; Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Time Until Patient is Ready for Discharge

  "readiness for discharge" to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty.

  Length of Hospital Stay, an expected average of 3 days

Study Arms (2)

Peri-Articular Injection

EXPERIMENTAL

Procedure: Peri-Articular Injection

Epidural Patient Controlled Analgesia (Epidural PCA)

ACTIVE COMPARATOR

Procedure: Epidural Patient Controlled Analgesia (Epidural PCA)

Interventions

Peri-Articular Injection PROCEDURE

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

Peri-Articular Injection

Epidural Patient Controlled Analgesia (Epidural PCA) PROCEDURE

Epidural analgesia pathway.

Epidural Patient Controlled Analgesia (Epidural PCA)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Kethy Jules-Elysee, MD
• Organization: Hospital for Special Surgery

juleselyseek@hss.edu

2126061206

Study Officials

• Kethy M Jules-Elysee, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: August 6, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Last Updated: April 14, 2022
• Results First Posted: May 10, 2016

Record last verified: 2022-04

Locations

US (1)