Comparing two methods of pain relief after abdominal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.