Status:
NOT_YET_RECRUITING
Intrathecal Morphine Versus Epidural Analgesia for Laparoscopic Colon Surgery
Lead Sponsor:
Meri Mirceta
Conditions:
Postoperative Pain
Analgesia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 analge...
Detailed Description
Participants of this study will be randomly selected adult patients with colorectal carcinoma undergoing laparoscopic colorectal resection who fulfill the inclusion criteria and sign the informed cons...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06881563
Start Date
March 1 2025
End Date
August 1 2026
Last Update
March 18 2025
Active Locations (1)
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1
University Hospital Split
Split, Croatia, 21000