Actively Recruiting
Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial
Led by Meri Mirceta ยท Updated on 2025-04-20
98
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two pain relief methods for adults undergoing open colorectal cancer surgery: intrathecal morphine, a single spinal injection, and continuous epidural analgesia. It focuses on evaluating how well each method controls pain at rest and during movement after surgery, while also considering side effects, patient satisfaction, sleep quality, and recovery outcomes. Participants are randomly assigned to one of two groups. The epidural group receives a catheter placed in the thoracic epidural space with a mixture of fentanyl and levobupivacaine continuously infused for 24 hours after surgery. The spinal group receives a single injection of preservative-free morphine into the lower spine. Both groups follow a standard multimodal pain management plan including additional medications as needed. Rescue treatments for nausea and severe itching are also provided. During the study, participants will be monitored closely with pain assessments at multiple time points up to 72 hours after surgery, along with evaluations of analgesic use, satisfaction, sleep quality, recovery speed, hospital stay length, and any side effects or complications. The main measure is pain intensity at rest 24 hours post-surgery. Follow-up includes observation of safety and recovery for up to 90 days after surgery.
CONDITIONS
Brief 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 blood clotting or ongoing therapeutic anticoagulation
- Low platelet count (thrombocytopenia)
- Skin infection at the site of spinal or epidural injection
- Existing neurological deficits including peripheral neuropathy
- Dementia or communication difficulties
- Bradycardia (pulse less than 50/min) or severe heart conduction block
- History of opioid abuse
- Allergy to any drugs used in the study
- Conversion from laparoscopy to open surgery due to technical issues
- Postoperative surgical complications requiring revision
- Unsuccessful epidural catheter placement or spinal anesthesia despite senior anesthesiologist attempt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and up to 24 hours after surgery
Participants undergo open colorectal cancer surgery and receive either intrathecal morphine or thoracic epidural analgesia during and after surgery to manage pain.
1 surgery visit and close monitoring during the first 24 hours post-surgery
Duration - Up to 90 days after surgery
Participants are monitored for pain intensity, analgesic consumption, side effects, quality of sleep, recovery, and complications up to 90 days after surgery.
Multiple assessments including visits at 1, 3, 6, 24, 48, and 72 hours and follow-up visits up to 90 days
Trial Site Locations
Total: 1 location
1
University hospital of Split
Split, Croatia, 21000
Actively Recruiting
Research Team
S
Svjetlana Doลกenoviฤ, MD, PhD
M
Meri Mirฤeta, MD
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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