Comparing two pain relief methods for open colon surgery
Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial
PHASE4 · University Hospital of Split · NCT06935708
This study is testing whether a single dose of spinal morphine or continuous epidural pain relief works better for managing pain after open colon surgery for cancer patients.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital of Split (other) |
| Locations | 1 site (Split) |
| Trial ID | NCT06935708 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intrathecal morphine versus continuous epidural analgesia for pain management in patients undergoing open colorectal cancer surgery. Participants will be randomly assigned to either the epidural group, receiving continuous epidural analgesia, or the spinal group, receiving a single dose of intrathecal morphine. The primary outcome is pain intensity at rest measured 24 hours post-surgery, while secondary outcomes include analgesic consumption, patient satisfaction, and length of hospital stay. The study aims to determine which method provides better pain relief and fewer side effects during recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with colorectal carcinoma undergoing laparoscopic abdominal surgery.
Not a fit: Patients with abnormal coagulation function, pre-existing neurologic deficits, or a history of opioid abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing open colorectal surgery.
How similar studies have performed: Previous studies have shown varying success with similar analgesia methods, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Split
- University hospital of Split — Split, Croatia (RECRUITING)
Study contacts
- Study coordinator: Svjetlana Došenović, MD, PhD
- Email: sdosenovic@yahoo.com
- Phone: +38521556180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Carcinoma, Analgesia, Postoperative, Laparotomy, postoperative pain, analgesia, epidural, intrathecal morphine, laparotomy