An interventional study of Alvimopan and Placebo in Ileus and Spinal Fusion, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-17.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
124 studies on the registry are indexed under Ileus; 12 are open to participants now.
This study's enrollment of 31 is below the median of 97 across 106 interventional studies indexed under Ileus.
Browse Ileus studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.
Drug: Alvimopan
Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven
Drug: Placebo
Also known as: Entereg
Also known as: Sugar Pill
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.
Time frame: 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.
Time frame: 14 days or until hospital discharge whichever occurs first
Complications and Adverse Event
Number of patients with complication/adverse event.
Time frame: 14 days or until hospital discharge, which ever occurs first
| Milestone | Alvimopan | Placebo - Sugar Pill |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 13 |
| Not completed | 0 | 0 |
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.
| Hours | Alvimopan | Placebo - Sugar Pill |
|---|---|---|
| Recovery of Bowel Function | 43.2 ± 23.1 | 34.0 ± 16.7 |
To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF.
| Hours | Alvimopan | Placebo - Sugar Pill |
|---|---|---|
| Length of Hospital Stay | 122.5 ± 48.4 | 117.2 ± 30.2 |
Number of patients with complication/adverse event.
| Participants | Alvimopan | Placebo - Sugar Pill |
|---|---|---|
| Complications and Adverse Event | 0 | 0 |
Collected over Adverse events were collected up to 6 weeks after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alvimopan | — | 2/13 (15.4%) | 0/13 (0%) |
| Placebo - Sugar Pill | — | 3/13 (23.1%) | 0/13 (0%) |
| Event | Alvimopan | Placebo - Sugar Pill |
|---|---|---|
| Venothromboembolic EventBlood and lymphatic system disorders | 1/13 | 1/13 |
| Postoperative HematomaSurgical and medical procedures | 1/13 | 1/13 |
| Screw malpositionSurgical and medical procedures | 0/13 | 1/13 |
| Age, Continuous(years) | Alvimopan | Placebo - Sugar Pill | Total |
|---|---|---|---|
| Mean | 49.2 ± 17.5 | 54.7 ± 13.7 | 52.0 ± 15.6 |
| Sex: Female, Male(Participants) | Alvimopan | Placebo - Sugar Pill | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 4 | 5 | 9 |
| Race and Ethnicity Not Collected(Participants) | Alvimopan | Placebo - Sugar Pill | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine