Spinal Anesthesia For Enhanced Recovery After Liver Surgery

Official Title

Spinal Anesthesia for Enhanced Recovery After Liver Surgery

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.

Trial Description

Primary Outcome:

  • Cumulative 72-hour volume of intravenous fluids and blood products administered
  • Area under the curve over 72 hours of the summed pain intensity difference scores at rest (AUC-SPID-PAR_0-72h)
  • Cumulative 72-hour opioid consumption (OC_0-72h)
Secondary Outcome:
  • Vasopressor-free days to day 30
  • Cumulative intraoperative vasopressor and/or inotrope consumption
  • Cumulative perioperative vasopressor and/or inotrope consumption
  • Cumulative 72-hour volume of intravenous fluids administered
  • Area under the curve over 72 hours of the summed pain intensity difference scores of movement-evoked pain (MEP) (AUC-SPID-MEP_0-72h)
  • Cumulative incidence (proportion) of rescue analgesia (parenteral opioid) use (%)
  • Cumulative fluid balance (CFB) at 72 hours
  • Percentage fluid overload (% FO) at 72 hours
  • Volume-related weight gain (VRWG) at 72 hours
  • Quality of recovery, as measured by the change from baseline 15-item Quality of Recovery (QoR-15) scale score over the first 72 hours postoperatively
  • Time to mobilization (h)
  • Time to gastrointestinal (GI) recovery (h)
  • Time to removal of urinary catheter (h)
  • Time to adequate pain control with PO medications (h)
  • Sleep disturbance, as measured by the change from baseline Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v1.0 - Sleep Disturbance 8a scale T-score over the first 7 days postoperatively
  • Overall Benefit of Analgesia Score (OBAS) at 72 hours
  • Index hospitalization length of stay
  • Analgesic-related adverse events: incidence rate ratio of severe respiratory depression
  • Analgesic-related adverse events: incidence rate ratio of sedation
  • Analgesic-related adverse events: cumulative incidence (proportion) of postoperative delirium
  • Number (count) of surgical complications with Clavien-Dindo grade ≥ III
  • Number (count) of non-surgical complications based on the Postoperative Morbidity Survey (POMS)
  • Comprehensive Complication Index (CCI) score Comprehensive Complication Index (CCI) score Comprehensive Complication Index (CCI) score
Hepatic resection surgery (hepatectomy) for primary or metastatic malignancy is a major operation involving large, painful upper abdominal incisions, as well as considerable postoperative physiological derangements.

Uncontrolled postoperative incisional pain results in significant respiratory impairment, delayed mobilization, and augmentation of the surgically-induced stress response, placing patients at increased risk of postoperative complications and chronic post-surgical pain. Acute pain management with high-dose parenteral opioids further compounds this risk. Multimodal opioid-sparing therapy, and regional anesthesia in particular, is therefore an essential component of enhanced recovery after surgery (ERAS) pathways and patient-centred care.

Regional anesthesia using neuraxial block (intraoperative spinal anesthesia or thoracic epidural anesthesia) followed by postoperative continuous thoracic epidural analgesia (CTEA; postoperative administration of epidural local anesthetic and/or opioid) is the best method for treating pain following large abdominal surgeries, including liver resection, and has been shown to improve postoperative respiratory function and decrease respiratory complications in other surgeries.

However, the effects of intraoperative neuraxial block and postoperative CTEA on fluid balance, systemic hemodynamics, and functional recovery after hepatic resection surgery remain controversial. CTEA is frequently associated with postoperative hypotension, resulting in increased perioperative intravenous (IV) fluid administration, red blood cell transfusion, and vasopressor use in liver resection patients. For major hepatectomies, CTEA may also be an independent risk factor for postoperative acute kidney injury (AKI), presumably due to impairment of renal autoregulation. Excessive IV fluid administration in the postoperative period is associated with significant weight gain, often necessitating diuretic therapy; delayed return of gastrointestinal function; increased need for packed red blood cell (pRBC) transfusion due to hemodilution; increased infective complications due to this increased pRBC transfusion rate; and increased length of hospital stay.

In addition, concerns remain about the use of CTEA following liver resection surgery due to the potentially increased risk of epidural hematoma formation in the setting of postoperative coagulopathy. This concern has resulted in unplanned delays in epidural catheter removal postoperatively, due to persistent coagulation abnormalities, prolonging hospitalization by 1-3 d in up to 15% of patients.

These concerns about the consequences of excess fluid administration and the safety of CTEA for liver resection surgery have prompted the use of alternative and/or ancillary analgesic techniques, particularly for major resections and in patients with preoperative liver dysfunction, for whom a prolonged period of postoperative coagulopathy is anticipated.

Intraoperative spinal anesthesia (SA) using local anesthetic (LA) and/or opioid (most commonly intrathecal morphine [ITM]) for neuraxial block without CTEA is frequently used as postoperative analgesia for various surgeries. Spinal anesthesia using ITM without LA has been reported in four randomized and three non-randomized studies of patients undergoing liver resections. ITM has provided superior analgesia to IV patient-controlled analgesia (IV-PCA) with opioids, and equivalent analgesia to epidural infusions. Compared with CTEA and/or IV-PCA, ITM was associated with reduced IV fluid administration; earlier mobilization, and resumption of normal dietary intake; decreased incidence of respiratory complications; and decreased hospital length of stay.

Spinal anesthesia using both LA and ITM may provide an additional benefit by providing a degree of preemptive analgesia, as well as by decreasing the stress and inflammatory response, thereby possibly decreasing the incidence of surgical stress-related complications such as postoperative delirium. High-spinal anesthesia (HSA) uses larger doses of LA to achieve a "high" block for this purpose. HSA combined with ITM has been used in cardiac surgery, and decreases the stress and inflammatory response to surgery; facilitates early extubation; improves postoperative analgesia; decreases the incidence of postoperative delirium; and decreases intensive care unit (ICU) readmissions. Neither the use of HSA (with or without ITM) for analgesia following non-cardiac surgical procedures, nor the effectiveness of SA with ITM versus CTEA following hepatic resection surgery has been investigated to date.

View this trial on ClinicalTrials.gov

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