Actively Recruiting
Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery
Led by Meri Mirceta · Updated on 2025-04-20
98
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 recovery are expected to be similar in both groups. By evaluating these methods, this study aims to determine the most effective and safe approach to post-surgical pain management, improving comfort and recovery outcomes for patients.
CONDITIONS
Official Title
Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients with colorectal carcinoma undergoing laparoscopic abdominal surgery aged 18-80 years
- ASA classification I-III
- Body Mass Index (BMI) between 15 and 35 kg/m2
You will not qualify if you...
- Abnormal coagulation function defined as prothrombin time or activated partial prothrombin time above standard laboratory values or international normalized ratio (INR) 21.4
- Receiving ongoing therapeutic anticoagulation
- Thrombocytopenia with platelet count below 80 x 10^9 L-1
- Pre-existing skin infection at the neuraxial anesthesia puncture site
- Pre-existing neurologic deficit including peripheral neuropathy
- Dementia or medical condition causing communication difficulties
- Bradycardia with pulse below 50/min or conduction block (2nd or 3rd degree)
- History of opioid abuse
- Allergies to any drugs used in the study
- Patients converted from laparoscopy to laparotomy due to surgical issues
- Postoperative surgical complications requiring revision
- Unsuccessful epidural catheter placement or spinal anesthesia after senior anesthesiologist attempt
AI-Screening
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Trial Site Locations
Total: 1 location
1
University hospital of Split
Split, Croatia, 21000
Actively Recruiting
Research Team
S
Svjetlana Došenović, MD, PhD
CONTACT
M
Meri Mirčeta, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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