Alvimopan Use in Polytraumatized Patients

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.

Official Title
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A Double Blind, Randomized, Parallel Design Study to Evaluate the Effectiveness of Post-operative Dose of Alvimopan(Entereg) in Preventing Post-operative Ileus in Poly-traumatized Patients

Conditions
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Post Operative Ileus

Intervention / Treatment
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* Drug: Alvimopan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 to 80 Poly-traumatized patients Extubated patients after abdominal exploration Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen Exclusion Criteria: Mechanically ventilated patients Patient not expected to survive Glasgow Coma Scale = 3 Pregnant patients Apache score > 40 (observed mortality 100%) Saas Ahmed Naved et al 2011 Vasopressor therapy Septic patients Thoracotomy Bogota bag Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit Patients with prior history of gastric surgery and/or colonic surgery Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction Prior pancreatic anastomosis or gastric anastomosis; ostomy formation Chronic use of nonsteroidal anti-inflammatory drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Will create a double blind, randomized, parallel design study to evaluate the effectiveness of Alvimopan(post operative dose) in preventing post-operative ileus in poly-traumatized patients
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alvimopan<br>Patients in the study group will be administered a post operative dose of Alvimopan | Drug: Alvimopan<br>* Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive Alvimopan ( post operative dose only) and will monitor for post operative ileus.<br>* Other names: Entereg;|
| Placebo Comparator: Placebo<br>Patients in the Placebo group will receive a placebo pill and will be compared with the study group | Drug: Placebo<br>* Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive the Placebo Pill (post operative dose only) and will monitor for post operative ileus.<br>* Other names: placebo pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo. | Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus hence the bowel recovery will be faster. By physical examination (passage of flatus, bowel movements upon auscultation) will be used to assess recovery of bowel function | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in patients of the same population who receive a placebo. | Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus and all the associated complications that prolonged the length of stay of the patients, hence it will reduce the hospital days of the individual | 5 years |