Phase 4
Completed N=49
Trial of Alvimopan in Major Spine Surgery
Source: ClinicalTrials.gov NCT02789111 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Time to First Bowel Movement — 50; 64 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The Investigator has chosen to study the reconstructive spinal surgery patient population because it is believed that the use of alvimopan in these patients at the University of Virginia will give the scientific community significant insight into the broader applicability of this drug into other surgical populations, the impact of this drug on the perception of pain (as opposed to simply the consumption of opioids), and its impact on total hospital charges, resource utilization, and functional outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Bowel Movement |
50; 64 | — |
| SECONDARY Time to Resumption of PO Intake |
17; 14.5 | — |
Eligibility Criteria
Inclusion Criteria
- Major spine surgery scheduled as part of clinical care
- 18-80 years
Exclusion Criteria
- More than three doses of any opioid within one week of surgery
- Pregnancy
- Prisoners
- Unable to provide consent
- Emergency surgery
- Chronic kidney disease stage 5 (GFR < 15 ml/min)
- Severe hepatic impairment
- Recent myocardial infarction (within the last 3 months)
Data sourced from ClinicalTrials.gov (NCT02789111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.