Spinal Anesthesia For Enhanced Recovery After Liver Surgery (SAFER-L)

This is an interventional treatment trial for Hepatectomy focused on measuring Injections, Spinal, Analgesia, Epidural, Anesthesia, Spinal, Patient Reported Outcome Measures, Postoperative Period Read More

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.