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N/A N=90 Randomized Triple-blind Treatment

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

Osteoarthritis

Enrolled (actual)
90
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Time Until Patient is Ready for Discharge — 2.4; 2.3 days

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Peri-Articular Injection (Procedure); Epidural Patient Controlled Analgesia (Epidural PCA) (Procedure)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Hospital for Special Surgery, New York
Primary completion
May 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Time Until Patient is Ready for Discharge
2.4; 2.3

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01658072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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