Comparing two methods of pain relief after abdominal surgery
Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia
PHASE2; PHASE3 · University of Iowa · NCT06559969
This study is testing two different ways to give pain relief after abdominal surgery to see which one helps patients feel better and recover faster.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06559969 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two methods for administering opioids for pain management following laparotomy. Participants aged 18 to 85 undergoing open upper abdominal surgery will be randomly assigned to receive either intravenous opioids alongside a continuous epidural local anesthetic or a combination of opioids and local anesthetic delivered through the epidural. The study will assess pain control, patient satisfaction, side effects, and recovery metrics over a period of 4 to 5 days post-surgery. Data will be collected through daily assessments and patient-controlled administration devices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 scheduled for open abdominal surgery who can consent to and tolerate an epidural.
Not a fit: Patients with contraindications for epidurals, chronic opioid use, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing major abdominal surgery.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of intravenous versus epidural opioid administration is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age including and between 18 to 85 years old 2. Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days 3. Patient has consented for an epidural 4. Patient is able to converse in English 5. Patient is able to use a patient controlled pump Exclusion Criteria: 1. Has a known contraindication for an epidural 2. Known mental or cognitive disability 3. History of chronic opioid use or substance abuse disorder 4. Pre-operative use of opioids 5. History of chronic pain 6. Routine use of marijuana 7. Incarcerated 8. Unable to converse in English 9. Planned to remain intubated post-operatively 10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter 11. End stage renal disease or dialysis 12. Hepatic disease that affects metabolism of drugs 13. Known contraindication to any of the study drugs 14. Known pregnancy or positive pre-operative pregnancy test 15. Known neurological condition that may affect motor or sensory systems
Where this trial is running
Iowa City, Iowa
- University of Iowa Health Care — Iowa City, Iowa, United States (RECRUITING)
Study contacts
- Principal investigator: Melinda Seering, MD — Univeristy of Iowa
- Study coordinator: Melinda Seering, MD
- Email: Melinda-Seering@uiowa.edu
- Phone: 3193848411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Laparotomy, Epidural, PCEA, PCA, Hydromorphone, bupivacaine, analgesia, laparotomy