Ancillary Effects of Oral Naloxegol (Movantik)
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Naloxegol 25 MG; Placebo
Intervention description: Oral Naloxegol 25 MG; matching oral placebo
Intervention MeSH terms: Naloxegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Effect of Naloxegol on reversing opioid-related side effects in patients recovering from elective primary hip surgery under spinal anesthesia who will be randomly assigned to oral Naloxegol or placebo for two postoperative days or until the date of discharge, whichever occurs earlier. The design will be a randomized, double-blind, placebo-controlled trial of oral Naloxegol in adults having elective primary hip or knee surgery under spinal anesthesia. The study will be performed at the Cleveland Clinic hospitals.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out whether oral Naloxegol can reduce the side effects
      of opioid painkillers following surgery. This study aims to explore whether Naloxegol can
      similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery
      patients will participate in this study which is being conducted at Cleveland Clinic Main
      Campus.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female or male aged at least 18 years

          3. American Society of Anesthesiologists physical status 1-4;

          4. Scheduled for elective primary hip or knee surgery under spinal anesthesia;

          5. Expected to receive intravenous patient-controlled analgesia (IV PCA)

          6. Expected to have significant postoperative pain

          7. Negative pregnancy test

        Exclusion Criteria:

          1. Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes

          2. Severe renal impairment, or creatinine level > 2.0

          3. History of bladder cancer

          4. Patients receiving perioperative regional anesthesia blocks

          5. Presence of a sacral nerve stimulator

          6. Medications (anticholinergic agents such as antihistamines, phenothiazines,
             antidepressants, antipsychotics), conditions or comorbidity causing urinary retention

          7. Patient with requirement of urinary catheter insertion before or immediately
             post-surgery due to immobility

          8. Urinary Tract Infections and other urogenital comorbidity (incontinence,
             cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary
             retention

          9. Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract
             malignancies, or peritoneal metastases

         10. Patients with known or suspected disruption of blood brain barrier, which may include
             but not limited to: Alzheimer's disease, stroke, poliomyelitis, cerebral palsy,
             multiple sclerosis, spinal lesions, and Parkinson's disease

         11. Gastrointestinal obstruction/Gastrointestinal perforation

         12. Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and
             antidepressants), Strong CYP3A4 inducers, Other opioid antagonists

         13. Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients