Recruiting

Spinal Anesthesia

Sponsor:

University of Manitoba

Code:

NCT03715517

Conditions

Hepatectomy

Pain, Postoperative

Liver Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous thoracic epidural analgesia

Spinal anesthesia with intrathecal morphine

Bupivacaine 0.75% in Dextrose Inj 8.25%

Morphine

Bupivacaine 0.25% Preservative-Free Injectable Solution

Study Details

Brief 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

Study ID

NCT03715517

Start date

Oct 4, 2018

Status verified date

Feb, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Jul 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female, Adults aged ≥ 18 years (there will be no upper age restriction);
  • American Society of Anesthesiologists Physical Status classification (ASA-PS) of I to III;
  • 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;
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Provision of signed and dated informed consent form
  • Body mass index (BMI) between 17 and 40 kg·m-², inclusive;
  • Negative result on serum pregnancy test at Screening and negative urine pregnancy test at Baseline (for women of childbearing potential, defined as those who have not undergone a hysterectomy or been postmenopausal for at least 12 consecutive months); and not currently breastfeeding, or planning to do so within 7 d following surgery;
  • Stated willingness and ability to comply with all study and/or follow-up evaluations and communicate clearly with the Investigator and staff; and
  • Voluntary participation and ability to provide written informed consent prior to any study procedures.

Exclusion Criteria:

  • Emergency surgery;
  • Age < 18 years;
  • Planned laparoscopic hepatic resection;
  • Planned laparotomy incision other than (right) subcostal, midline, or extended midline;
  • Patients with obvious non-resectable disease prior to signing informed consent;
  • Liver transplant recipient or previous hepatic resection or living-donor hepatectomy surgery;
  • Major surgery (open abdominal and/or thoracic) under general anesthesia ≤ 30 d preoperatively;
  • Contraindications to neuraxial (spinal or epidural) anesthesia: (a) anticipated difficult intubation; (b) coagulation or hemostatic abnormalities within 30 d of surgery (defined as thrombocytopenia \[platelet count < 100 × 10⁹ L-¹\]; INR > 1.4; or activated partial thromboplastin time \[aPTT\] > 40 s); (c) bleeding diathesis; (d) ongoing use (≤ 7 d before surgery) or planned perioperative use of antiplatelet agents (apart from acetylsalicylic acid 81 mg) or anticoagulants (excluding deep-vein thrombosis prophylaxis); (e) recent (≤ 30 d preoperatively) systemic infection or current (≤ 48 h) fever (≥ 38.4 °C), or evidence of infection (including superficial cutaneous infection in the thoracic and/or lumbar regions); (f) history of neurologic disorder affecting the spinal cord or the hemithorax or below; or impaired bladder/bowel function; (g) acute or subacute (≤ 90 d preoperatively) intracranial hemorrhage; or (h) technical contraindications to epidural placement: (i) local skin or soft tissue infection at proposed site for thoracic epidural insertion; (ii) previous cervicothoracic, thoracic, or thoracolumbar spinal surgery; (iii) history of spinal tumor, fracture or infection; or (iv) recent (≤ 14 d preoperatively) epidural corticosteroid injection;
  • Significant cardiac arrhythmias (including pacemaker-dependence) or clinically significant cardiovascular disease (New York Heart Association \[NYHA\] functional classification III-IV);
  • Volume overload (hyperhydration), particularly in cases of pulmonary edema or acute decompensated congestive heart failure (CHF);
  • Acute kidney injury (AKI) and/or chronic kidney disease (CKD) based on the 2012 Kidney Disease Improving Global Outcomes (KDIGO) AKI (excluding the oliguria criterion) and CKD guideline definitions: AKI: increase in serum creatinine (SCr) (≥ 26.5 μmol·L-¹ within 48 h or ≥ 1.5× baseline within 7 d); CKD: abnormalities of kidney structure or function, present for > 3 mo, defined as either of the following present for > 3 mo: (1) ≥ 1 marker(s) of kidney damage: (a) albuminuria (24-h albumin-creatinine ratio \[ACR\] ≥ 30 mg·g-¹ \[≥ 3 mg·mmol-¹\]), (b) urine sediment abnormalities, (c) electrolyte and other abnormalities due to tubular disorders, (d) abnormalities detected by histology, (e) structural abnormalities detected by imaging, (f) history of kidney transplantation; and/or decreased glomerular filtration rate (GFR < 60 mL-¹·min-¹·1.73 m-², estimated using the 2009 CKD-EPI creatinine equation \[eGFR\_creat\]);
  • Severe hypernatremia (\[Na⁺\] ≥ 155 mmol·L-¹) and/or hyperchloremia (\[Cl-\] ≥ 125 mmol·L-¹);
  • Chronic pain; current (≤ 30 d preoperatively) and/or prior chronic (for a period of ≥ 90 d) opioid use; or history of alcohol, opiate, and/or other drug abuse or dependence;
  • Use of supraphysiologic glucocorticoid (GC) doses (≥ 7.5 mg·day-¹ of prednisone or equivalent): recent (≤ 30 d), prolonged (> 2 consecutive weeks), or multiple courses totalling > 3 weeks in the preceding 6 months;
  • Known allergy or sensitivity (e.g., glucose-6-phosphate dehydrogenase \[G6PD\] deficiency) to amide local anesthetics, opioids, or acetaminophen, or hypersensitivity to other materials to be used in the study (e.g., latex \[epidural catheter adapter\], epidural dressing or tape); or
  • Altered mental status or educational, psychiatric, or communication (language, literacy) barriers that would impede accurate assessment of postoperative pain and/or ability to complete questionnaire instruments.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intrathecal morphine

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)

active comparator: Thoracic epidural analgesia

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).

Interventions

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

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

Bupivacaine 0.75% in Dextrose Inj 8.25%

0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%

Morphine

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

Bupivacaine 0.25% Preservative-Free Injectable Solution

0.25 mg⋅kg-¹ bupivacaine 0.25%

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

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

Primary outcome measure

  • Cumulative 72-hour volume of intravenous fluids and blood products administered [ Time Frame: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier ]
  • Area under the curve over 72 hours of the summed pain intensity difference scores at rest (AUC-SPID-PAR_0-72h) [ Time Frame: 72 hours after surgery or until hospital discharge, whichever occurs earlier ]
  • Cumulative 72-hour opioid consumption (OC_0-72h) [ Time Frame: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier ]

Central Contacts and Locations

Central contacts

Alex Grunfeld, MD

204-787-1125alexander.grunfeld@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0Z2

Contacts

Alex Grunfeld, MD

204-787-1125alexander.grunfeld@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Injections, Spinal
  • Analgesia, Epidural
  • Anesthesia, Spinal
  • Patient Reported Outcome Measures
  • Postoperative Period

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-02-05.