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Minimal Opioid Use After Total Hip Replacement (THR)

NCT03090152 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-12-27

Study results available
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Summary

Total hip arthroplasty can be associated with significant postoperative pain. Side effects of pain management may impair participation in physical therapy and slow readiness for discharge from the hospital. In a previous study done by the investigators' group, epidural patient controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more favorable pain profile with ambulation, but greater side effects compared to injection of a peri-articular cocktail. The use of opioid was greater in the peri-articular injection group (PAI). There was no difference in length of stay. In view of the controversy over opioid use, the investigators would like to develop an optimal opioid sparing pain management approach by comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain control while minimizing opioid use and side-effects.

Conditions

  • Osteoarthritis, Hip

Interventions

PROCEDURE

Periarticular injection (Deep injection)

Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.

PROCEDURE

Periarticular injection (Superficial injection)

Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.

DRUG

Bupivacaine

EPCA: Bupivacaine 0.06%.

DRUG

Placebo

EPCA: Saline.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Kethy Jules-Elysee, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2019-06-28
Completion
2019-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090152 on ClinicalTrials.gov