RecruitingPhase 4NCT06935708

Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery

Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial

Sponsor

Meri Mirceta

Enrollment

98 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Carcinoma Analgesia, Postoperative Laparotomy

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 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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two methods of pain control after open colon surgery: a single injection of morphine directly into the spinal fluid (intrathecal morphine) versus an epidural catheter (a tube placed in the back that continuously delivers pain medication). The goal is to find out which approach provides better pain relief with fewer side effects. **You may be eligible if...** - You are scheduled for open colon surgery (such as for colon cancer or inflammatory bowel disease) - You are an adult in adequate health for major abdominal surgery - You do not have contraindications to spinal or epidural anesthesia **You may NOT be eligible if...** - You have bleeding disorders or take blood thinners that cannot be stopped safely - You have infections near the injection site - You have a history of severe reactions to opioid medications - You have significant spinal deformities or prior spine surgery that makes placement difficult - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntrathecal Morphine

In Spinal group, 25 G or 27 G pencil point needle, depending on the preference of the anesthesiologist, will be inserted at L2-L3 or L3-L4 intervertebral space and 300 μg of preservative-free morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) diluted with sterile saline to a volume of 3 mL will be injected intrathecally.

PROCEDUREEpidural Analgesia

Epidural analgesia with levobupivacaine and fentanyl mixture. For intraoperative intermittent analgesia, Epidural group will be given a loading dose of 5-10 milliliters of a mixture of 10 micrograms per milliliter (μg/mL) of fentanyl (Fentanyl Piramal Critical Care, 50 mcg/ml) and 0.25% levobupivacaine (Levobupivakain Kabi 5 mg/ml), followed by intermittent 4-5 mL boluses as needed throughout the surgery. Postoperative continuous epidural analgesia in the epidural group will consist of 2 μg/mL fentanyl added to 0.1 % levobupivacaine at the rate 5-8 mL/h during the first 24 hours after surgery.