Ancillary Effects of Oral Naloxegol (Movantik)

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Naloxegol

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