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Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery

RecruitingPhase 4Ages 18 Years - 80 YearsAllMeri Mirceta
NCT06935708 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Effective pain management after abdominal surgery is essential for recovery. This study compares two pain relief methods-intrathecal morphine (a single spinal injection) and continuous epidural analgesia-for patients undergoing open colorectal cancer surgery. The investigators expect intrathecal morphine to provide equal pain relief at rest 24 hours after surgery, while epidural analgesia may be more effective during movement. By 48 to 72 hours, both methods should offer similar pain control. The epidural group may require fewer additional pain medications but could experience more side effects, including a higher risk of low blood pressure and technical difficulties. Additionally, these patients may have a slightly longer hospital stay. In contrast, the intrathecal morphine group may have fewer overall side effects. Despite these differences, patient satisfaction, sleep quality, and re

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intrathecal Morphine
  • Epidural Analgesia
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Where

1 site
University hospital of Split
Split, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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