NCT06935708 Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery
| NCT ID | NCT06935708 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Meri Mirceta |
| Condition | Colorectal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 98 participants in total. It began in 2025-04-08 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06935708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06935708 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06935708 currently recruiting?
Yes, NCT06935708 is actively recruiting participants. Contact the research team at sdosenovic@yahoo.com for enrollment information.
Where is the NCT06935708 trial being conducted?
This trial is being conducted at Split, Croatia.
Who is sponsoring the NCT06935708 clinical trial?
NCT06935708 is sponsored by Meri Mirceta. The trial plans to enroll 98 participants.