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Local Anesthetic

Intrathecal morphine for Liver Tumors (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

SAFER-L Trial 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.Check my eligibility

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.See study design

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.

SAFER-L Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

Select...

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

SAFER-L Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

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

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

Secondary outcome measures

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

+20 more

Other outcome measures

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

SAFER-L 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

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,353 Total Patients Enrolled

Alex Grunfeld, MDPrincipal InvestigatorUniversity of Manitoba

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on how many participants can join this experiment?

"Yes, as per information listed on clinicaltrials.gov this trial is actively recruiting individuals for participation. This medical research was posted to the website in October of 2018 with its last edit being made in December 2023; 128 people are expected to join at a single location."

Answered by AI

Are there any vacancies remaining to participate in this research?

"Affirmative. Evidenced on clinicaltrials.gov, this experiment is actively seeking patients to fill the 128 participant quota for its single site. This trial was initially posted in October 2018 and last updated in December 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Anesthesia For Enhanced Recovery After Liver Surgery

Alex Grunfeld 2018. "Spinal Anesthesia For Enhanced Recovery After Liver Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03715517.

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