Spinal Anesthesia For Enhanced Recovery After Liver Surgery

Launched by UNIVERSITY OF MANITOBA · Oct 20, 2018

Keywords

ClinConnect Summary

This clinical trial is looking to compare two types of anesthesia—spinal anesthesia and epidural anesthesia—for patients undergoing liver surgery, specifically liver resection or hepatectomy. The researchers believe that spinal anesthesia might help control blood pressure better after surgery and reduce the need for extra fluids, while still providing effective pain relief. They also hope that using spinal anesthesia will help patients recover more quickly.

To participate in this study, you need to be an adult aged 18 or older, scheduled for elective liver surgery, and in good general health (classified as ASA I to III). You should be willing to follow the study procedures and provide informed consent. If you decide to join, you can expect to receive either spinal or epidural anesthesia during your surgery, and the team will monitor your recovery closely to see how well each method works. It's important to know that certain conditions may prevent you from participating, such as emergency surgery or serious health issues.

Gender

ALL

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.