Constipation Clinical Trial
Official title:
Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures
Patients requiring opioids for post-operative pain control following elective orthopedic procedures which has resulted in constipation symptoms, and who are in inpatient rehabilitation will be randomized to two different treatment arms: lubiprostone or senna. Baseline scores regarding constipation and a quality of life bowel questionnaire will be compared the day following 6 days of treatment intervention.
The purpose of this study is to assess the efficacy of Lubiprostone (Amitiza) compared to
standard care for the treatment of constipation in orthopedic patients receiving opioids for
pain control during inpatient rehabilitation. Lubiprostone (Amitiza®) is a locally acting
chloride channel activator that increases intestinal fluid, and thus increases intestinal
motility. It has been approved for chronic constipation, but not in the setting of
opioid-induced constipation. Senna is a stimulant laxative that increases propulsive
peristaltic activity of the colon through local effects on the mucosa.
Subjects will be compared using from the Patient Assessment of Constipation (PAC) which has
previously been found to be a valid and reliable way to measure constipation symptoms and
clinical course. (Frank, Kleinman et al. 1999) as well as with other measures of
bowel-related symptoms and functional outcomes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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