Spinal Anesthesia for Liver Surgery
(SAFER-L Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using antiplatelet agents or anticoagulants (except for low-dose aspirin), you may need to stop them before surgery.
What evidence supports the effectiveness of the drug used in spinal anesthesia for liver surgery?
Research shows that intrathecal morphine, when used with spinal anesthesia, provides effective and long-lasting pain relief after surgery. Studies indicate that it can significantly extend the time before patients need additional pain medication, with minimal side effects when used in low doses.12345
Is spinal anesthesia with intrathecal morphine safe for humans?
Spinal anesthesia with intrathecal morphine is generally safe when used in low doses, as it provides effective pain relief with minimal side effects. However, higher doses can lead to serious adverse events, such as respiratory depression, nausea, vomiting, and itching. Careful dosing is important to ensure safety.12467
How does the drug 'Spinal anesthesia with intrathecal morphine' differ from other treatments for liver surgery?
Spinal anesthesia with intrathecal morphine is unique because it combines a spinal block with morphine directly injected into the spinal fluid, providing powerful and prolonged pain relief with minimal disturbance to brain function. This method is particularly effective for postoperative pain control, offering long-lasting analgesia with lower doses of morphine, which reduces the risk of side effects like respiratory depression.12348
What is the purpose of this trial?
This project proposes to compare epidural versus spinal anesthesia in patients having liver resection surgery. The investigators hypothesize that spinal anesthesia will result in improved blood pressure control postoperatively and reduce the amount of intravenous fluids required after surgery. Spinal anesthesia is expected to provide the same pain control benefits as epidurals, with faster recovery of function. Spinal anesthesia may be a simple and effective way to improve and enhance the recovery in the increasing number of patients requiring liver resection.
Research Team
Alex Grunfeld, MD
Principal Investigator
University of Manitoba
Eligibility Criteria
This trial is for adults over 18 who need elective liver resection surgery and can consent to the study. They should have a BMI between 17-40, be in stable physical condition (ASA-PS I to III), and not be pregnant or breastfeeding. The surgery shouldn't include extra procedures adding more than an hour.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo liver resection surgery with either spinal anesthesia or thoracic epidural analgesia
Postoperative Monitoring
Participants are monitored for fluid balance, pain intensity, and opioid consumption for 72 hours post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including vasopressor-free days and complications
Treatment Details
Interventions
- Bupicavaine 0.125% epidural solution
- Bupivacaine 0.25% Preservative-Free Injectable Solution
- Bupivacaine 0.75% in Dextrose Inj 8.25%
- Hydromorphone 10 mcg/mL epidural solution
- Morphine
- Spinal anesthesia with intrathecal morphine
Spinal anesthesia with intrathecal morphine is already approved in United States, European Union, Canada for the following indications:
- Pain management for surgical procedures
- Anesthesia for liver resection surgery
- Pain management for surgical procedures
- Anesthesia for various surgeries including liver resection
- Pain management for surgical procedures
- Anesthesia for liver resection and other surgeries
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor