The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT03235739
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Cleveland, Ohio, 44195, United States
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), constipation and nausea/vomiting. Clinical evidence demonstrates that Naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral Naloxegol 25 MG
Other names: Movantik
matching oral placebo
Time frame: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first
Residual urine volume in the bladder as assessed by bladder scan
Time frame: Postoperative days 1-2 or until day of discharge whichever occurs first
Opioid-related Symptom Distress Scale (ORSDS) is a 4 point-scale that evaluates three symptom distress dimensions (frequency, severity, bothersomeness) for opioid-related side effects. The 12 elements of the ORSDS are nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness, lightheaded, fatigue, feeling confused, itchiness, dry mouth, and headache. The ORSDS questionnaire was administered by a trained investigator on first and second postoperative days while patients remained hospitalized. We reported the average ORSDS score from all 12 elements, which ranged from 0 to 4 and higher scores represent worse outcome.
Time frame: Postoperative days 1-2 or until day of discharge whichever occurs first
Number of patients receiving Naloxegol requiring indwelling urinary catheters
Time frame: Postoperative Days 2 or discharge day whichever was earlier
Quality of recovery is a validated scoring system that quantifies patients' early postoperative health status with range of 0-150 where higher score means better quality of recovery. We used the 15-question version, the QoR-15
The Cleveland Clinic
Other
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