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| Name | Class |
|---|---|
| Orthopedic Research and Education Foundation | OTHER |
| Barnes-Jewish Hospital | OTHER |
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The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.
Posterior spinal fusion (PSF) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (POI) and concomitant increased length of hospital stay (LOHS). POI is exacerbated by high dose opiate consumption often required by these patients post-operatively. We propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce POI in bowel resection. We hypothesize that alvimopan will shorten POI in spine fusion patients without negatively affecting post-operative pain control. Treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control.
We hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (POI) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (PSF). The study will be a randomized, double-blinded, placebo-controlled pilot trial. Reducing the morbidity of POI in patients undergoing PSF will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alvimopan | Experimental | Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven. |
|
| Placebo - Sugar Pill | Placebo Comparator | Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvimopan | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of Bowel Function | To determine the effect of alvimopan on the recovery of bowel function as determined by time to first bowel movement in patients undergoing posterior spinal fusion. The effect size calculated may guide a larger, multicenter randomized controlled study. Time was measured from wound closure to bowel movement. | 14 days or until hospital discharge whichever occurs first |
| Length of Hospital Stay | To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF. | 14 days or until hospital discharge whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Complications and Adverse Event | Number of patients with complication/adverse event. | 14 days or until hospital discharge, which ever occurs first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Kelly, MD | Department of Orthopedic Surgery - Washington University in St. Louis School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital / Washington University in St. Louis School of Medicine | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11755891 | Background | Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001 Nov;182(5A Suppl):3S-10S. doi: 10.1016/s0002-9610(01)00781-4. | |
| 17909274 | Background | Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Am J Health Syst Pharm. 2007 Oct 15;64(20 Suppl 13):S3-7. doi: 10.2146/ajhp070428. |
| Label | URL |
|---|---|
| Summary Review for Regulatory Action | View source |
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5 Patients enrolled and withdrew prior to undergoing randomization, surgery and treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Alvimopan | Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven. Alvimopan |
| FG001 | Placebo - Sugar Pill | Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alvimopan | Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven. Alvimopan |
| BG001 | Placebo - Sugar Pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recovery of Bowel Function | To determine the effect of alvimopan on the recovery of bowel function as determined by time to first bowel movement in patients undergoing posterior spinal fusion. The effect size calculated may guide a larger, multicenter randomized controlled study. Time was measured from wound closure to bowel movement. | Posted | Mean | Standard Deviation | Hours | 14 days or until hospital discharge whichever occurs first |
|
Adverse events were collected up to 6 weeks after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alvimopan | Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven. Alvimopan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venothromboembolic Event | Blood and lymphatic system disorders | Systematic Assessment | Unrelated to intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael P. Kelly, MD, MSc | Washington University School of Medicine | 314-747-2511 | kellymi@wustl.edu |
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| ID | Term |
|---|---|
| D045823 | Ileus |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C419502 | alvimopan |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Drug |
|
|
| 16076918 | Background | Leslie JB. Alvimopan for the management of postoperative ileus. Ann Pharmacother. 2005 Sep;39(9):1502-10. doi: 10.1345/aph.1E615. Epub 2005 Aug 2. |
| 15135926 | Background | Holzer P. Opioids and opioid receptors in the enteric nervous system: from a problem in opioid analgesia to a possible new prokinetic therapy in humans. Neurosci Lett. 2004 May 6;361(1-3):192-5. doi: 10.1016/j.neulet.2003.12.004. |
| 12656645 | Background | Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63(7):649-71. doi: 10.2165/00003495-200363070-00003. |
| 15357847 | Background | Sternini C, Patierno S, Selmer IS, Kirchgessner A. The opioid system in the gastrointestinal tract. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:3-16. doi: 10.1111/j.1743-3150.2004.00553.x. |
| 15017498 | Background | Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012. |
| 11091234 | Background | Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x. |
| 8057274 | Background | Zimmerman DM, Gidda JS, Cantrell BE, Schoepp DD, Johnson BG, Leander JD. Discovery of a potent, peripherally selective trans-3,4-dimethyl-4-(3-hydroxyphenyl)piperidine opioid antagonist for the treatment of gastrointestinal motility disorders. J Med Chem. 1994 Jul 22;37(15):2262-5. doi: 10.1021/jm00041a003. |
| 15906123 | Background | Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA; Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum. 2005 Jun;48(6):1114-25; discussion 1125-6; author reply 1127-9. doi: 10.1007/s10350-005-0035-7. |
| 11180040 | Background | Liu SS, Hodgson PS, Carpenter RL, Fricke JR Jr. ADL 8-2698, a trans-3,4-dimethyl-4-(3-hydroxyphenyl) piperidine, prevents gastrointestinal effects of intravenous morphine without affecting analgesia. Clin Pharmacol Ther. 2001 Jan;69(1):66-71. doi: 10.1067/mcp.2001.112680. |
| 16333556 | Background | Viscusi ER, Goldstein S, Witkowski T, Andonakakis A, Jan R, Gabriel K, Du W, Techner L, Wallin B. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006 Jan;20(1):64-70. doi: 10.1007/s00464-005-0104-y. Epub 2005 Dec 7. |
| 15383800 | Background | Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, Wallin BA; Alvimopan Postoperative Ileus Study Group. Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004 Oct;240(4):728-34; discussion 734-5. doi: 10.1097/01.sla.0000141158.27977.66. |
| 19086236 | Background | Buchler MW, Seiler CM, Monson JR, Flamant Y, Thompson-Fawcett MW, Byrne MM, Mortensen ER, Altman JF, Williamson R. Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicentre, placebo-controlled clinical study. Aliment Pharmacol Ther. 2008 Aug 1;28(3):312-25. doi: 10.1111/j.1365-2036.2008.03696.x. |
| 17617331 | Background | Wolff BG, Viscusi ER, Delaney CP, Du W, Techner L. Patterns of gastrointestinal recovery after bowel resection and total abdominal hysterectomy: pooled results from the placebo arms of alvimopan phase III North American clinical trials. J Am Coll Surg. 2007 Jul;205(1):43-51. doi: 10.1016/j.jamcollsurg.2007.02.026. Epub 2007 May 17. |
Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven
Placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Length of Hospital Stay | To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF. | Posted | Mean | Standard Deviation | Hours | 14 days or until hospital discharge whichever occurs first |
|
|
|
| Secondary | Complications and Adverse Event | Number of patients with complication/adverse event. | Posted | Count of Participants | Participants | 14 days or until hospital discharge, which ever occurs first |
|
|
|
| 2 |
| 13 |
| 0 |
| 13 |
| EG001 | Placebo - Sugar Pill | Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven Placebo | 3 | 13 | 0 | 13 |
|
| Postoperative Hematoma | Surgical and medical procedures | Systematic Assessment |
|
| Screw malposition | Surgical and medical procedures | Systematic Assessment |
|
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