RecruitingNot ApplicableNCT03715517

Spinal Anesthesia For Enhanced Recovery After Liver Surgery

Spinal Anesthesia for Enhanced Recovery After Liver Surgery

Sponsor

University of Manitoba

Enrollment

128 participants

Start Date

Oct 4, 2018

Study Type

INTERVENTIONAL

Conditions

Pain, Postoperative Liver Neoplasms Hepatectomy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding a spinal anesthesia injection (a type of local anesthesia delivered into the lower spine) to standard general anesthesia helps patients recover faster and with less pain after liver surgery, compared to general anesthesia alone. **You may be eligible if...** - You are 18 or older - You are scheduled for planned (non-emergency) open liver removal surgery under general anesthesia - Your physical health classification is ASA I–III (a standard medical fitness rating) - Your BMI is between 17 and 40 - You are able to give informed consent and follow up after surgery **You may NOT be eligible if...** - Your surgery is an emergency - Your surgery is planned as laparoscopic (keyhole) liver surgery - You have had a prior liver transplant or previous liver surgery - You have had major abdominal or chest surgery within the past 30 days - You have blood clotting problems or are on certain blood thinners that make spinal anesthesia unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREContinuous 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

PROCEDURESpinal 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

DRUGBupivacaine 0.75% in Dextrose Inj 8.25%

0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%

DRUGMorphine

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

DRUGBupivacaine 0.25% Preservative-Free Injectable Solution

0.25 mg⋅kg-¹ bupivacaine 0.25%

DRUGBupicavaine 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

DRUGHydromorphone 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