Phase 4
Completed N=49
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501
Retraction of Colostomy
Source: ClinicalTrials.gov NCT01509638 ↗
Enrolled (actual)
49
Serious AEs
6.4%
Results posted
Mar 2014
Primary outcomePrimary: Total Opioid Burden — 67.7; 38.41 mg morphine equivalent
Summary
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Burden |
67.7; 38.41 | — |
| PRIMARY Health Economic Benefits |
7284.63; 7010.16 | — |
| PRIMARY Health Economic Benefit |
4; 3 | — |
| SECONDARY Incidence of Opioid-related Adverse Events |
0.1; 0.1 | — |
| SECONDARY Patient Satisfaction With Postsurgical Analgesia |
8; 11; 7; 9; 1; 2 | — |
| SECONDARY Patient Discharged From Hospital for at Least 3 Days |
16; 22 | — |
| SECONDARY Patient Made Unplanned Visit(s) With Any Healthcare Providers |
2; 4 | — |
| SECONDARY Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery |
5; 2 | — |
| SECONDARY Experienced Health Problems or Changes in Health Since Hospital Discharge |
4; 5 | — |
| SECONDARY Time to First Opioid Administration |
0.7; 1.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years of age or older.
- Patients scheduled to undergo ileostomy reversal.
- Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.
Exclusion Criteria
- Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
- Patients who abuse alcohol or other drug substance.
- Patients with severe hepatic impairment.
- Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least one month before and one month after dosing.
- Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
- Patients who have participated in an EXPAREL study within the last 30 days.
- Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.
In addition, the patient will be ineligible if he/she meets the following criteria during surgery:
- Patients who have any concurrent surgical procedure.
- Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
- Patients who receive Entereg(R).
Data sourced from ClinicalTrials.gov (NCT01509638). 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.