Conditions: Constipation
Keywords: constipation opioid rehabilitation post-operative orthopedic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days with two tabs placebo Senna at noon arm 2: Senna 2 tabs daily for 6 days at noon and placebo Lubiprostone 1 Cap BID

Interventions: intervention 1: Lubiprostone intervention 2: Senna
Intervention descriptions: intervention 1: 24 µg po BID given with meals for 6 days intervention 2: 2 tabs daily for 6 days

Protocol document: