NCT06935708RecruitingPhase 4
Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery
Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 13 Apr 2025
- Start date
- 8 Apr 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Meri Mirceta
- Diseases
- Colorectal cancer
- NCT number
- NCT06935708
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 98
- From 8 Apr 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- pre-existing skin infection at the neuraxial anesthesia puncture site,
- patients with dementia or other medical condition that includes communication difficulties,
- 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.
Lab values
- 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,
Other
- pre-existing neurologic deficit, including peripheral neuropathy,
- patients with bradycardia (pulse \<50/min) or with conduction block (2nd or 3rd degree)
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital of Split Coordinator of this site? Confirm its status | Split | Croatia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.