Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients
| Status: | Terminated |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/18/2018 |
| Start Date: | January 2017 |
| End Date: | February 2018 |
A Double-blind, Randomized, Placebo-controlled Trial of Naloxegol for Prevention of Post-operative Constipation in Spinal Surgery Patients
Constipation is a known complication of the postoperative period after spinal surgery, where
prescription pain medicines called opioids are traditionally used in high doses for the
treatment of surgery-related pain. The goal of this study is to determine the effectiveness
of Movantik (naloxegol)—a FDA-approved drug used to treat constipation that is caused by
opioids—in preventing constipation in patients undergoing spinal fusion surgery at MGH.
prescription pain medicines called opioids are traditionally used in high doses for the
treatment of surgery-related pain. The goal of this study is to determine the effectiveness
of Movantik (naloxegol)—a FDA-approved drug used to treat constipation that is caused by
opioids—in preventing constipation in patients undergoing spinal fusion surgery at MGH.
Inclusion Criteria:
- Male or female patients between the ages of 18 and 75 years undergoing non-urgent,
elective spinal fusion at Massachusetts General Hospital who are admitted to the
neurosurgery floor from the operating room
Exclusion Criteria:
- Patients who are taken to the operating room from another inpatient floor or service
(already hospitalized prior to surgery)
- Patients with evidence of bowel obstruction
- Patients unable to take oral medications by mouth or by enteric feeding tube
(gastrostomy or jejunostomy)
- Patients with a documented or potential allergy or adverse reaction to Movantik
(naloxegol) from outpatient use
- Patients currently taking Movantik (naloxegol) in the outpatient setting
- Patients with a preoperative diagnosis of irritable bowel syndrome (IBS) obtained via
Rome III questionnaire on screening
- Patients with disruptions to the blood-brain barrier (eg, multiple sclerosis, recent
brain injury, Alzheimer's disease, and uncontrolled epilepsy)
- Patients with a history of cancer.
- Patients concomitantly using strong CYP3A4 inhibitors (eg, clarithromycin,
ketoconazole), strong CYP3A4 inducers and other opioid antagonists.
- Patients with severe hepatic impairment.
- Patients with a previous history of or risk of bowel perforation.
- Patients with a post-op regional anesthetic technique employed like a continuous
epidural or spinal.
- Patients for which local anesthetics will be placed in the wound.
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