Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention
Condition: Postoperative Ileus
MeSH terms: Ileus
Intervention: Methylnaltrexone; Placebo
Intervention description: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.; Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
Intervention MeSH terms: Methylnaltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized in a 1:1 fashion to receive methylnaltrexone or placebo. Participants will remain in the group they are randomized to for the duration of the study.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal Arthrodesis; Ileus; Postoperative Ileus; Adult Spinal Deformity

Summary:

      This randomized controlled trial will prospectively evaluate the clinical benefit for
      subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation)
      effects of spinal surgery without increasing narcotic usage or otherwise disrupting the
      recovery course of patients. Using a double-blind randomized design, either subcutaneous MNTX
      (0.15 mg/kg rounded to 8 mg or 12 mg) or placebo will be administered starting before surgery
      and then daily for three days. Information will be collected from medical records in IHIS up
      to 30 days prior to surgery and then for up to 30 days after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is scheduled to undergo a 1 - 3 level lumbar spinal fusion for degenerative
             spinal conditions including neurogenic claudication and/or lumbar radiculopathy with
             stenosis and/or spondylolisthesis.

          -  Subject must be over the age of 18 years old.

          -  Subject has been unresponsive to conservative care for a minimum of 6 months.

          -  The subject must in the investigator's opinion, be psychosocially, mentally, and
             physically able to fully comply with this protocol and have the ability to understand
             and give written informed consent.

        Exclusion Criteria:

          -  Previous Treatment with MNTX

          -  History of mechanical gastrointestinal obstruction

          -  History of OIC refractory to outpatient medical management

          -  Presence of a peritoneal catheter for intraperitoneal chemotherapy or dialysis

          -  Clinically relevant active diverticular disease

          -  Recent history of bowel surgery within previous 12 months

          -  Use of vinca alkaloids within previous four months

          -  Renal failure defined as Estimated Glomerular Filtration Rate (eGFR) <30 ml/min per
             1.73 m^2 or requires dialysis

          -  Known or suspected allergy to MNTX or similar compounds (e.g. naltrexone or naloxone)

          -  Participation in a study with investigational products within 30 days before first
             dose of MNTX

          -  Pregnant or nursing

          -  Clinically important abnormalities that may interfere with participation or compliance
             to the study, as determined by investigator.