[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100340668":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":63,"centralContacts":67,"locations":72,"responsibleParty":88,"collaborators":31,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":31,"enrollmentInfo":101,"targetDuration":31,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of Manitoba","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intrathecal morphine","EXPERIMENTAL","Spinal anesthesia with intrathecal morphine\n\nBolus (pre-induction): High-spinal anesthesia with 0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75% plus 3 mcg⋅kg-¹ intrathecal morphine (preservative-free)\n\nPostoperative analgesia: IV-PCA hydromorphone (bolus: 0.2 mg \\[range: 0.1-0.4 mg\\]; 5 min lockout; no infusion)",[13,14,15],"Procedure: Spinal anesthesia with intrathecal morphine","Drug: Bupivacaine 0.75% in Dextrose Inj 8.25%","Drug: Morphine",{"label":17,"type":18,"description":19,"interventionNames":20},"Thoracic epidural analgesia","ACTIVE_COMPARATOR","Continuous thoracic epidural analgesia\n\nBolus (pre-induction): 0.25 mg⋅kg-¹ bupivacaine 0.25% plus 1 mcg⋅kg-¹ hydromorphone (0.1 mL⋅kg-¹)\n\nInfusion (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)\n\nInfusion (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)\n\nPostoperative 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).",[21,22,23,24],"Procedure: Continuous thoracic epidural analgesia","Drug: Bupivacaine 0.25% Preservative-Free Injectable Solution","Drug: Bupicavaine 0.125% epidural solution","Drug: Hydromorphone 10 mcg\u002FmL epidural solution",[26,32,36,43,48,54,60],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Continuous thoracic epidural analgesia","Needle\u002Fcatheter: 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)\n\nLevel 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\n\nConfirmation 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",[17],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Spinal anesthesia with intrathecal morphine","Needle\u002Fcatheter: 25 Ga. × 90 mm high-flow Whitacre spinal needle (Becton-Dickinson, Franklin Lakes, NJ, USA)\n\nLevel of insertion and patient positioning: L2-L3, lateral decubitus position during injection; immediately post-injection, patient is placed supine in \\\u003C5% degree of Trendelenburg\n\nConfirmation of correct placement: Aspiration of cerebrospinal fluid",[9],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Bupivacaine 0.75% in Dextrose Inj 8.25%","0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%",[9],[42],"Spinal heavy bupivacaine",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Morphine","3 mcg⋅kg-¹ intrathecal morphine (preservative-free)",[9],[9],{"type":37,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Bupivacaine 0.25% Preservative-Free Injectable Solution","0.25 mg⋅kg-¹ bupivacaine 0.25%",[17],[53],"Bupivacaine 0.25% epidural solution",{"type":37,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"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",[17],[59],"Bupivacaine 0.125% preservative-free injectable solution",{"type":37,"name":61,"description":56,"armGroupLabels":62,"otherNames":31},"Hydromorphone 10 mcg\u002FmL epidural solution",[17],[64],{"name":65,"affiliation":5,"role":66},"Alex Grunfeld, MD","PRINCIPAL_INVESTIGATOR",[68],{"name":65,"role":69,"phone":70,"phoneExt":31,"email":71},"CONTACT","204-787-1125","alexander.grunfeld@umanitoba.ca",[73],{"facility":5,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"RECRUITING","Winnipeg","Manitoba","R3E 0Z2","Canada","CA",{"type":81,"coordinates":82},"Point",[83,84],-97.14704,49.8844,{"lat":84,"lon":83},[87],{"name":65,"role":69,"phone":70,"phoneExt":31,"email":71},{"type":66,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Alex Grunfeld","Principal Investigator","100340668","spinal-anesthesia-for-enhanced-recovery-after-liver-surgery-100340668",false,"NCT03715517","Spinal Anesthesia For Enhanced Recovery After Liver Surgery","Spinal Anesthesia for Enhanced Recovery After Liver Surgery","SAFER-L","Inclusion Criteria:\n\n* Male or female, Adults aged ≥ 18 years (there will be no upper age restriction);\n* American Society of Anesthesiologists Physical Status classification (ASA-PS) of I to III;\n* 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;\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Provision of signed and dated informed consent form\n* Body mass index (BMI) between 17 and 40 kg·m-², inclusive;\n* 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;\n* Stated willingness and ability to comply with all study and\u002For follow-up evaluations and communicate clearly with the Investigator and staff; and\n* Voluntary participation and ability to provide written informed consent prior to any study procedures.\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Age \\\u003C 18 years;\n* Planned laparoscopic hepatic resection;\n* Planned laparotomy incision other than (right) subcostal, midline, or extended midline;\n* Patients with obvious non-resectable disease prior to signing informed consent;\n* Liver transplant recipient or previous hepatic resection or living-donor hepatectomy surgery;\n* Major surgery (open abdominal and\u002For thoracic) under general anesthesia ≤ 30 d preoperatively;\n* 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 \\\u003C 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\u002For lumbar regions); (f) history of neurologic disorder affecting the spinal cord or the hemithorax or below; or impaired bladder\u002Fbowel 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;\n* Significant cardiac arrhythmias (including pacemaker-dependence) or clinically significant cardiovascular disease (New York Heart Association \\[NYHA\\] functional classification III-IV);\n* Volume overload (hyperhydration), particularly in cases of pulmonary edema or acute decompensated congestive heart failure (CHF);\n* Acute kidney injury (AKI) and\u002For 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\u002For decreased glomerular filtration rate (GFR \\\u003C 60 mL-¹·min-¹·1.73 m-², estimated using the 2009 CKD-EPI creatinine equation \\[eGFR\\_creat\\]);\n* Severe hypernatremia (\\[Na⁺\\] ≥ 155 mmol·L-¹) and\u002For hyperchloremia (\\[Cl-\\] ≥ 125 mmol·L-¹);\n* Chronic pain; current (≤ 30 d preoperatively) and\u002For prior chronic (for a period of ≥ 90 d) opioid use; or history of alcohol, opiate, and\u002For other drug abuse or dependence;\n* 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;\n* 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\n* Altered mental status or educational, psychiatric, or communication (language, literacy) barriers that would impede accurate assessment of postoperative pain and\u002For ability to complete questionnaire instruments.","ALL","18 Years",{"count":102,"type":103},128,"ESTIMATED","INTERVENTIONAL",[106],"NA","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.",[109,110,111],"Hepatectomy","Pain, Postoperative","Liver Neoplasms",[113,114,115,116,117],"Injections, Spinal","Analgesia, Epidural","Anesthesia, Spinal","Patient Reported Outcome Measures","Postoperative Period","2026-02-03",{"date":120,"type":121},"2026-02-05","ACTUAL",{"date":123,"type":121},"2018-10-04",{"date":125,"type":103},"2031-12-31",{"name":5,"class":6},1]