Comparing spinal and epidural anesthesia for liver surgery recovery

Spinal Anesthesia for Enhanced Recovery After Liver Surgery

This study is testing whether spinal anesthesia can help people recovering from liver surgery feel better and recover faster compared to epidural anesthesia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Manitoba (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT03715517 on ClinicalTrials.gov

What this trial studies

This project aims to compare the effectiveness of spinal anesthesia versus epidural anesthesia in patients undergoing liver resection surgery. The hypothesis is that spinal anesthesia will lead to better blood pressure control and reduced intravenous fluid requirements postoperatively. By providing similar pain control benefits as epidurals, spinal anesthesia is expected to facilitate faster recovery of function. This approach is part of a multimodal strategy to enhance recovery after surgery for patients with liver neoplasms.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are undergoing elective liver resection surgery and meet specific health criteria.

Not a fit: Patients with severe comorbidities or those requiring extensive additional surgical procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery outcomes and reduced complications for patients undergoing liver surgery.

How similar studies have performed: Previous studies have shown that regional anesthesia can improve postoperative outcomes in similar surgical contexts, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Winnipeg, Manitoba

• University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)

Study contacts

• Principal investigator: Alex Grunfeld, MD — University of Manitoba
• Study coordinator: Alex Grunfeld, MD

Conditions Hepatectomy; Pain, Postoperative; Liver Neoplasms; Injections, Spinal; Analgesia, Epidural; Anesthesia, Spinal; Patient Reported Outcome Measures; Postoperative Period