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Local Anesthetic

Spinal Anesthesia for Liver Surgery (SAFER-L Trial)

N/A

Recruiting

Led By Alex Grunfeld, MD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing subcostal or midline laparotomy for elective liver resection surgery under general anesthesia; if the planned procedure is a combined operation (i.e., concomitant extrahepatic surgery) , the associated procedure should not add more than one hour to the surgical time of the primary hepatic resection procedure alone;

American Society of Anesthesiologists Physical Status classification (ASA-PS) of I to III;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperatively and during the first 72 hours postoperatively

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will compare epidural and spinal anesthetics for liver resection surgery to see if spinal anesthesia can help reduce blood pressure & IV fluid use, while providing the same pain control & faster recovery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include low blood pressure, itching due to morphine use, urinary retention, nausea or vomiting from opioids like hydromorphone or morphine, and potential headaches from spinal injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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My health is good to moderately impaired according to the ASA scale.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperatively (from anesthesia start time to anesthesia end time)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperatively (from anesthesia start time to anesthesia end time)

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperatively (from anesthesia start time to anesthesia end time) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Cumulative 72-hour opioid consumption (OC_0-72h)

Cumulative 72-hour volume of intravenous fluids and blood products administered

Secondary study objectives

Analgesic-related adverse events: cumulative incidence (proportion) of postoperative delirium

Analgesic-related adverse events: incidence rate ratio of sedation

Analgesic-related adverse events: incidence rate ratio of severe respiratory depression

+18 more

Other study objectives

Area under the curve (AUC) over 24 hours of the summed pain intensity difference (SPID) scores at rest (AUC-SPID-PAR_0-24h)

Cumulative 24-hour (IV) opioid consumption (OC_0-24h)

Cumulative 24-hour volume of intravenous fluids and blood products administered

+3 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Morphine

FDA approved

0 / 2Eligibility criteria met