Ileus, Spinal Fusion
Conditions
Keywords
Alvimopan, Ileus, Posterior spinal fusion
Brief summary
The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.
Detailed description
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.
Interventions
DRUGAlvimopan
DRUGPlacebo
Sponsors
Orthopedic Research and Education Foundation
Barnes-Jewish Hospital
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis
Exclusion criteria
* pregnant women * ischemic heart disease * chronic liver or renal disease * prior bowel resection * presence of colostomy or ileostomy * gastroparesis * complete bowel obstruction * inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of Bowel Function | 14 days or until hospital discharge whichever occurs first | 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. |
| Length of Hospital Stay | 14 days or until hospital discharge whichever occurs first | To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications and Adverse Event | 14 days or until hospital discharge, which ever occurs first | Number of patients with complication/adverse event. |
Countries
United States
Participant flow
Pre-assignment details
5 Patients enrolled and withdrew prior to undergoing randomization, surgery and treatment
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Alvimopan | Placebo - Sugar Pill | Total |
|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 17.5 | 54.7 years STANDARD_DEVIATION 13.7 | 52.0 years STANDARD_DEVIATION 15.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 2 / 13 | 3 / 13 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alvimopan | Length of Hospital Stay | 122.5 Hours | Standard Deviation 48.4 |
| Placebo - Sugar Pill | Length of Hospital Stay | 117.2 Hours | Standard Deviation 30.2 |
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.
Time frame: 14 days or until hospital discharge whichever occurs first
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alvimopan | Recovery of Bowel Function | 43.2 Hours | Standard Deviation 23.1 |
| Placebo - Sugar Pill | Recovery of Bowel Function | 34.0 Hours | Standard Deviation 16.7 |
Secondary
Complications and Adverse Event
Number of patients with complication/adverse event.
Time frame: 14 days or until hospital discharge, which ever occurs first
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alvimopan | Complications and Adverse Event | 0 Participants |
| Placebo - Sugar Pill | Complications and Adverse Event | 0 Participants |