128 Participants Needed

Spinal Anesthesia for Liver Surgery

(SAFER-L Trial)

AG
Overseen ByAlex Grunfeld, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

AG

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

I am having liver surgery through a cut near my belly, and any extra surgery won't extend the time by more than an hour.
I am willing and able to follow all study rules and be available for its duration.
You have signed and dated a form saying you understand and agree to be in the study.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo liver resection surgery with either spinal anesthesia or thoracic epidural analgesia

1 week
Intraoperative and postoperative monitoring

Postoperative Monitoring

Participants are monitored for fluid balance, pain intensity, and opioid consumption for 72 hours post-surgery

72 hours
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including vasopressor-free days and complications

30 days
Regular follow-up visits

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
Trial Overview The study compares spinal anesthesia with intrathecal morphine against continuous thoracic epidural analgesia for pain control after liver surgery. It aims to see if spinal anesthesia leads to better blood pressure control, less fluid needed post-surgery, and quicker recovery.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intrathecal morphineExperimental Treatment3 Interventions
Spinal anesthesia with intrathecal morphine Bolus (pre-induction): High-spinal anesthesia with 0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75% plus 3 mcg⋅kg-¹ intrathecal morphine (preservative-free) Postoperative analgesia: IV-PCA hydromorphone (bolus: 0.2 mg \[range: 0.1-0.4 mg\]; 5 min lockout; no infusion)
Group II: Thoracic epidural analgesiaActive Control4 Interventions
Continuous thoracic epidural analgesia Bolus (pre-induction): 0.25 mg⋅kg-¹ bupivacaine 0.25% plus 1 mcg⋅kg-¹ hydromorphone (0.1 mL⋅kg-¹) Infusion (initial): 0.25 mg⋅kg-¹⋅h-¹ bupivacaine 0.25% plus 1 mcg⋅kg-¹⋅h-¹ hydromorphone (0.1 mL⋅kg-¹⋅h-¹) Infusion (range): 0.19-0. 3 mg⋅kg-¹⋅h-¹ bupivacaine 0.25% plus 0.75-1.25 mcg⋅kg-¹⋅h-¹ hydromorphone (0.075-0.125 mL⋅kg-¹⋅h-¹) (3-10 mL⋅h-¹) Postoperative analgesia: (1) Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range as above (0.075-0.125 mL⋅kg-¹⋅h-¹) (3-10 mL⋅h-¹), continued for a maximum of 72 h postoperatively; (2) IV-PCA hydromorphone (bolus: 0.2 mg \[range: 0.1-0.4 mg\]; 5 min lockout; no infusion).

Spinal anesthesia with intrathecal morphine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Spinal anesthesia with intrathecal morphine for:
  • Pain management for surgical procedures
  • Anesthesia for liver resection surgery
🇪🇺
Approved in European Union as Spinal anesthesia with intrathecal morphine for:
  • Pain management for surgical procedures
  • Anesthesia for various surgeries including liver resection
🇨🇦
Approved in Canada as Spinal anesthesia with intrathecal morphine for:
  • 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

Trials
628
Recruited
209,000+

Findings from Research

Intrathecal morphine is effective for postoperative pain control but is associated with high rates of side effects, including nausea (21.5%), vomiting (14.8%), and pruritus (59.5%) in a study of 1,306 patients.
The incidence and severity of these side effects are significantly correlated with factors such as female gender, cesarean section, and higher doses of morphine (over 0.2 mg), indicating a need for careful dosing and consideration of alternatives.
Nausea, vomiting and pruritus induced by intrathecal morphine.Chinachoti, T., Nilrat, P., Samarnpiboonphol, P.[2013]
In a study of 144 women undergoing abdominal hysterectomy, adding intrathecal morphine to bupivacaine significantly reduced the amount of morphine needed for pain relief in the first 24 hours after surgery, with the most effective dose being 200 μg.
No serious side effects were reported, and while pruritus was noted in morphine groups, overall side effects like nausea were similar across all groups, indicating that intrathecal morphine is a safe option for post-operative pain management.
Low dose intrathecal morphine effects on post-hysterectomy pain: a randomized placebo-controlled study.Hein, A., Rösblad, P., Gillis-Haegerstrand, C., et al.[2022]
Intrathecal morphine provided strong and long-lasting pain relief in a study of 32 surgical patients, with minimal impact on brain function, making it an effective analgesic option.
However, the study highlighted a significant risk of delayed respiratory depression, particularly in elderly patients, suggesting that lower doses should be used for this population to avoid serious complications.
Postoperative pain control with intrathecal morphine.Gjessing, J., Tomlin, PJ.[2019]

References

Nausea, vomiting and pruritus induced by intrathecal morphine. [2013]
Low dose intrathecal morphine effects on post-hysterectomy pain: a randomized placebo-controlled study. [2022]
Postoperative pain control with intrathecal morphine. [2019]
[Intrathecal morphine for postoperative pain]. [2013]
Intrathecal morphine: dosage and efficacy in younger patients for control of postoperative pain following spinal fusion. [2022]
Comparison of 75 and 150 μg doses of intrathecal morphine for postoperative analgesia after transurethral resection of the prostate under spinal anesthesia. [2014]
Serious Adverse Events after a Single Shot of Intrathecal Morphine: A Case Series and Systematic Review. [2022]
Intrathecal Morphine in the Presence of a Syrinx in Pediatric Spinal Deformity Surgery. [2021]
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