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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hospital for Special Surgery, New York.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01658072
First received: March 1, 2012
Last updated: February 4, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention
Osteoarthritis
Procedure: Peri-Articular Injection
Procedure: Epidural Patient Controlled Analgesia (Epidural PCA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Time Until Patient is Ready for Discharge [ Time Frame: Length of Hospital Stay, an expected average of 3 days ] [ Designated as safety issue: Yes ]
    "readiness for discharge" to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty.


Estimated Enrollment: 90
Study Start Date: February 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peri-Articular Injection Procedure: Peri-Articular Injection
Use of a different analgesic protocol, based on a peri-articular injection
Active Comparator: Epidural Patient Controlled Analgesia (Epidural PCA) Procedure: Epidural Patient Controlled Analgesia (Epidural PCA)
Epidural analgesia pathway.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658072

Contacts
Contact: Shane C Reid, MS 6467978536 reids@hss.edu
Contact: Carey Ford, BA 2127742602 fordc@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Shane C Reid, MS    646-797-8536    reids@hss.edu   
Principal Investigator: Kethy M Jules-Elysee, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Kethy M Jules-Elysee, MD Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01658072     History of Changes
Other Study ID Numbers: 11139
Study First Received: March 1, 2012
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Hospital for Special Surgery, New York:
Total Hip Arthroplasty
Total Hip Replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014