N/A
N=98
Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Colon Cancer · Rectal Cancer · Colonic Diverticulosis
Bottom Line
View on ClinicalTrials.gov: NCT01552226 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Postoperative Numerical Pain Score-Day 0 — 3.9; 2.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Preperitoneal Analgesia (Device); Continuous Epidural Analgesia (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trinity Health Michigan
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Numerical Pain Score-Day 0 |
3.9; 2.6 | — |
| PRIMARY Postoperative Numerical Pain Score-Day 1 |
3.2; 2.6 | — |
| PRIMARY Postoperative Numerical Pain Score-Day 2 |
2.6; 2.1 | — |
| PRIMARY Postoperative Numerical Pain Score-Day 3 |
2.9; 2.7 | — |
| PRIMARY Postoperative Numerical Pain Score-Day 4 |
3.1; 2.7 | — |
| PRIMARY Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU) |
3.5; 2.3 | — |
| SECONDARY Patient Use of Supplemental Narcotic Analgesia Day 1 |
29; 23 | — |
| SECONDARY Patient Use of Supplemental Narcotic Analgesia Day 2 |
22.4; 21.2 | — |
| SECONDARY Patient Use of Supplemental Narcotic Analgesia Day 3 |
17.4; 16.0 | — |
| SECONDARY Patient Use of Supplemental Narcotic Analgesia Day 4 |
6.9; 9.2 | — |
| SECONDARY Patient Use of Supplemental Narcotic Analgesia Day 0 |
20.5; 11.0 | — |
Summary
This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver Soaker™ catheters (CPA) is equivalent to continuous epidural analgesia (CEA).
Eligibility Criteria
Inclusion Criteria
- Age > = 18 years
- Scheduled for elective colon or rectal surgery
- Surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic)
- Able to provide informed consent
- Able to complete patient questionnaire
Exclusion Criteria
- Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl
- Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc)
- Urgent surgery precluding epidural catheter placement
- Systemic Infection contraindicating epidural catheter placement
- Unwillingness to participate in follow up assessments
- Prisoners
Data sourced from ClinicalTrials.gov (NCT01552226). 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.