Spinal Anesthesia For Enhanced Recovery After Liver Surgery

NCT03715517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-02-05

No results posted yet for this study

Summary

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.

Conditions

  • Hepatectomy
  • Pain, Postoperative
  • Liver Neoplasms

Interventions

PROCEDURE

Continuous thoracic epidural analgesia

Needle/catheter: 17 Ga. × 80 mm Tuohy epidural needle (Perican®, B. Braun Medical Inc., Bethlehem, PA, USA); Arrow FlexTip Plus® 19 Ga. epidural catheter (Arrow International Inc., Reading, PA, USA) Level of insertion and patient positioning: T6-T8, upright sitting position for insertion of needle and catheter (to 5 cm beyond loss-of-resistance point) and for injection of test dose (3 mL 2% lidocaine with epinephrine 1:200,000); supine for injection of bolus dose Confirmation of correct placement: Loss of resistance to air or saline; negative aspiration of the epidural catheter; negative test dose; and ease of injection of an initial bolus dose

PROCEDURE

Spinal anesthesia with intrathecal morphine

Needle/catheter: 25 Ga. × 90 mm high-flow Whitacre spinal needle (Becton-Dickinson, Franklin Lakes, NJ, USA) Level of insertion and patient positioning: L2-L3, lateral decubitus position during injection; immediately post-injection, patient is placed supine in \<5% degree of Trendelenburg Confirmation of correct placement: Aspiration of cerebrospinal fluid

DRUG

Bupivacaine 0.75% in Dextrose Inj 8.25%

0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%

DRUG

Morphine

3 mcg⋅kg-¹ intrathecal morphine (preservative-free)

DRUG

Bupivacaine 0.25% Preservative-Free Injectable Solution

0.25 mg⋅kg-¹ bupivacaine 0.25%

DRUG

Bupicavaine 0.125% epidural solution

Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range 0.075-0.125 mL⋅kg-¹⋅h-¹

DRUG

Hydromorphone 10 mcg/mL epidural solution

Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range 0.075-0.125 mL⋅kg-¹⋅h-¹

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Alex Grunfeld, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2031-07-31
Completion
2031-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715517 on ClinicalTrials.gov