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Completed

NCT Number: NCT03090152

Minimal Opioid Use After Total Hip Replacement (THR)

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

Long acting narcotics or scheduled doses of narcotics are often used as part of a multimodal pain regimen. In this study, this is eliminated. Instead, it uses a cocktail of different drugs including intraoperative Ketamine use (NMDA receptor antagonist), intra-op Benadryl (to decrease excitation of nociceptors) and IV Tylenol. The narcotic free regimen starts preoperatively with the use of Aspirin,Clonidine patch, Cymbalta (Duloxetine), and is maintained both intraoperatively and post operatively. Baby ASA (81mg) is being used as an anti-inflammatory agent. A number of studies including the one by Morris et al. (2009), have shown via in vitro experiments that low dose aspirin decreases polymorphonuclear leukocyte and macrophage accumulation. It inhibits thromboxane making it an antithrombotic agent as well. The concern with aspirin has been major bleeding. Several studies in the orthopedic patient population using ≤81 mg of aspirin have shown that it does not increase bleeding (Cuellar, Mantz). At HSS, patients are routinely continued on baby aspirin when needed for its cardio protective effect. Devereaux in the POISE trial did show an increased risk of bleeding when ASA was given preoperatively at a dose of 200 mg. In our study, all patients will be given intravenous tranexamic acid which should mitigate against the risk of bleeding. Duloxetine is also being added. In a recent study done at HSS. Duloxetine was found to decrease the amount of opioid use and nausea. If found to be more effective with the use of EPCA vs. PAI or combination of the two, a new way of managing postop pain while minimizing Nnartcuoreti co fu Ssetu adsy per CDC recommendation will be helpful in managing patients post-operatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
  • Planned use of regional anesthesia
  • Planned posterolateral surgical approach
  • Age Range 45-80
  • Ability to follow study protocol

Exclusion criteria

  • Any patient with age <45 or >80
  • Any patient with planned anterior surgical approach
  • Any patient with prior major ipsilateral hip surgery
  • Any patient intending to receive general anesthesia
  • Any patient with an ASA of IV
  • Any patient with insulin-dependent diabetes
  • Any patient with hepatic (liver) failure (history of cirrhosis or elevated LFT's)
  • Any patient with chronic renal (kidney) failure (formal diagnosis of renal disease of elevated creatinine)
  • Any patient with history of gastric (stomach) ulcer
  • Chronic opioid use (taking opioids for >3 mo duration on a daily basis)
  • Chronic analgesic use (i.e. lyrica, gabapentin) for >3 mo duration
  • Stress dose steroids
  • Use of antidepressants
  • Contraindications to aspirin
  • Allergy to any of the medications (or adhesives) involved in the study protocol
  • Dementia
  • Non-English speakers.

Treatment and study plan

Periarticular injection (Deep injection)

Procedure

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.

Periarticular injection (Superficial injection)

Procedure

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

Bupivacaine

Drug

EPCA: Bupivacaine 0.06%.

Placebo

Drug

EPCA: Saline.

Primary outcomes

  1. Opioid Use

    Time frame: within 24 hours after surgery

    Oral morphine equivalents, cumulative

Secondary outcomes

  1. Pain at Rest

    Time frame: Postoperative Day 1,2,3,7,90

    NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.

  2. Pain With Activity

    Time frame: Postoperative Day 1,2,3,7,90

    NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.

  3. Opioid Side Effects

    Time frame: Postoperative Day 1,2

    via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome.

  4. Patient Satisfaction

    Time frame: Postoperative Day 1,2,3,7

    via Likert scale. A higher score is a better outcome. the scale is from 0-10.

  5. Post-operative Pain

    Time frame: Postoperative Day 1

    via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.

  6. Neuropathic Pain Assessed With S-LANSS

    Time frame: Postoperative Day 7, Postoperative Day 90

    via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome.

  7. Quality of Recovery

    Time frame: Postoperative Day 1,2,3

    Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome

  8. Readiness for Discharge Time

    Time frame: From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.

    When patient meets all readiness for discharge criteria

  9. Blinding Assessment

    Time frame: Assessed on day of discharge and on seventh post operative day

    What group do you think you were in

  10. Opioid Consumption During the First 3 Days Post-op

    Time frame: Postoperative day 0,1,2,3

    Opioids consumed in the first 3 after surgery (cumulative consumption).

  11. No Opioids Consumed

    Time frame: 0 to 24 hours post-operatively

    Number of patients who did not consume any opioids

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Minimal Opioid Use After Total Hip Replacement (THR): a Blinded Randomized Placebo-controlled Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2017
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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