Actively Recruiting
Spinal Anesthesia for Enhanced Recovery After Liver Surgery comparing Intrathecal Morphine and Continuous Thoracic Epidural Analgesia
Led by University of Manitoba · Updated on 2026-02-05
128
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing spinal anesthesia to epidural anesthesia in adults undergoing liver resection surgery to see which method better controls blood pressure and reduces the need for intravenous fluids after surgery. The study aims to determine if spinal anesthesia offers similar pain relief benefits as epidural anesthesia while promoting faster recovery. This trial addresses concerns about fluid balance, respiratory complications, and safety related to epidural anesthesia in liver surgery patients. Participants receive either spinal anesthesia with intrathecal morphine or continuous thoracic epidural analgesia during surgery. The spinal anesthesia group receives a high-spinal dose of bupivacaine with intrathecal morphine before surgery and uses intravenous patient-controlled hydromorphone for pain afterward. The epidural group receives bupivacaine and hydromorphone through a thoracic epidural catheter before and after surgery, with continuous infusion for up to 72 hours postoperatively. During the study, participants are monitored for fluid and blood product use, pain levels at rest and with movement, opioid consumption, and various recovery measures such as mobilization, gastrointestinal function, and urinary catheter removal. Safety outcomes like respiratory depression, sedation, delirium, and complications are also tracked. The study collects data up to 30 days after surgery, including hospital stay length and postoperative complications, to evaluate recovery quality and analgesic effects.
CONDITIONS
Brief Title
Spinal Anesthesia For Enhanced Recovery After Liver Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with no upper age limit
- Male or female participants
- Physical status classification ASA-PS I to III
- Scheduled for elective liver resection surgery by open subcostal or midline laparotomy
- Combined surgeries allowed if the additional procedure adds no more than one hour
- Body mass index between 17 and 40 kg/m2 inclusive
- Women of childbearing potential must have negative pregnancy tests and not be breastfeeding or planning to breastfeed within 7 days after surgery
- Willingness and ability to comply with study procedures and follow-up
- Ability to provide written informed consent
You will not qualify if you...
- Emergency surgery cases
- Age under 18 years
- Planned laparoscopic liver resection
- Planned incision other than right subcostal, midline, or extended midline
- Presence of non-resectable liver disease before consent
- Previous liver transplant, hepatic resection, or living-donor hepatectomy
- Major abdominal or thoracic surgery within 30 days before study
- Contraindications to spinal or epidural anesthesia including difficult intubation, coagulation abnormalities, bleeding disorders, recent infection or fever, neurologic disorders affecting spinal cord, recent intracranial hemorrhage, or technical issues with epidural placement
- Significant cardiac arrhythmias or severe cardiovascular disease (NYHA III-IV)
- Volume overload conditions like pulmonary edema or acute heart failure
- Acute kidney injury or chronic kidney disease based on specific criteria
- Severe electrolyte imbalances (high sodium or chloride levels)
- Chronic pain or opioid use within 30 days before surgery, or history of substance abuse
- Recent or prolonged use of high-dose glucocorticoids
- Allergies or sensitivities to local anesthetics, opioids, acetaminophen, or study materials
- Mental status or communication barriers that prevent accurate pain assessment or questionnaire completion
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 - Up to 72 hours postoperatively
Participants undergo liver resection surgery with either spinal anesthesia using intrathecal morphine or continuous thoracic epidural analgesia for pain management around the time of surgery.
Surgery day and postoperative hospitalization period up to 3 days
Duration - Up to 7 days postoperatively
Participants are monitored for recovery including mobilization, gastrointestinal function, pain control, and potential complications up to 7 days after surgery or until hospital discharge.
Daily assessments during hospital stay
Trial Site Locations
Total: 1 location
1
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0Z2
Actively Recruiting
Research Team
A
Alex Grunfeld, 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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