Status:
COMPLETED
Ancillary Effects of Oral Naloxegol (Movantik)
Lead Sponsor:
The Cleveland Clinic
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 o...
Detailed Description
Opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder)...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 18 years
- American Society of Anesthesiologists physical status 1-4;
- Scheduled for elective primary hip or knee surgery under spinal anesthesia;
- Expected to receive intravenous patient-controlled analgesia (IV PCA)
- Expected to have significant postoperative pain
- Negative pregnancy test
Exclusion
- Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
- Severe renal impairment, or creatinine level \> 2.0
- History of bladder cancer
- Patients receiving perioperative regional anesthesia blocks
- Presence of a sacral nerve stimulator
- Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
- Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
- Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
- Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
- 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
- Gastrointestinal obstruction/Gastrointestinal perforation
- Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
- Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03235739
Start Date
October 1 2017
End Date
May 23 2022
Last Update
September 5 2023
Active Locations (1)
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1
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195