Comparing two pain relief methods for open colon 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 study evaluates the effectiveness of intrathecal morphine versus continuous epidural analgesia for pain management in patients undergoing open colorectal cancer surgery. Participants will be randomly assigned to either the epidural group, receiving continuous epidural analgesia, or the spinal group, receiving a single dose of intrathecal morphine. The primary outcome is pain intensity at rest measured 24 hours post-surgery, while secondary outcomes include analgesic consumption, patient satisfaction, and length of hospital stay. The study aims to determine which method provides better pain relief and fewer side effects during recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female patients with colorectal carcinoma undergoing laparoscopic abdominal surgery aged 18-80 years, ASA classification I-III, Body Mass Index (BMI) 15-35 kg/m2.

Exclusion Criteria:

* abnormal coagulation function, defined as prothrombin time or activated partial prothrombin time above standard laboratory values or an international normalised ratio (INR) ≥1.4; or receiving ongoing therapeutic anticoagulation,
* thrombocytopenia, defined as a platelet count \<80×10 9 L-1,
* pre-existing skin infection at the neuraxial anesthesia puncture site,
* pre-existing neurologic deficit, including peripheral neuropathy,
* patients with dementia or other medical condition that includes communication difficulties,
* patients with bradycardia (pulse \<50/min) or with conduction block (2nd or 3rd degree)
* history of opioid abuse,
* allergies to any of the drugs used in the study.

Additionally, patients converted from laparoscopy to laparotomy due to technical surgical issues, patients with postoperative surgical complications (need for revision) or if epidural catheter placement/spinal anesthesia is unsuccessful even after an attempt by a senior anesthesiologist will also be excluded.

Where it's running

• University hospital of Split
  Split, Croatia Recruiting

Study contacts

• Study coordinator: Svjetlana Došenović, MD, PhD
• Email: sdosenovic@yahoo.com
• Phone: +38521556180

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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.