Health TrialsbyHealthPanel

Spinal Anesthesia For Enhanced Recovery After Liver Surgery

ConditionsHepatectomyPain, PostoperativeLiver Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergency surgery;

Age < 18 years;

Planned laparoscopic hepatic resection;

Planned laparotomy incision other than (right) subcostal, midline, or extended midline;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous thoracic epidural analgesia

    Procedure/Surgery

    Needle/catheter: 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) Level 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 Confirmation 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

  • Spinal anesthesia with intrathecal morphine

    Procedure/Surgery

    Needle/catheter: 25 Ga. × 90 mm high-flow Whitacre spinal needle (Becton-Dickinson, Franklin Lakes, NJ, USA) Level of insertion and patient positioning: L2-L3, lateral decubitus position during injection; immediately post-injection, patient is placed supine in \<5% degree of Trendelenburg Confirmation of correct placement: Aspiration of cerebrospinal fluid

  • Bupivacaine 0.75% in Dextrose Inj 8.25%

    Drug

    0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%

  • Morphine

    Drug

    3 mcg⋅kg-¹ intrathecal morphine (preservative-free)

  • Bupivacaine 0.25% Preservative-Free Injectable Solution

    Drug

    0.25 mg⋅kg-¹ bupivacaine 0.25%

  • Bupicavaine 0.125% epidural solution

    Drug

    Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range 0.075-0.125 mL⋅kg-¹⋅h-¹

  • Hydromorphone 10 mcg/mL epidural solution

    Drug

    Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range 0.075-0.125 mL⋅kg-¹⋅h-¹

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Intrathecal morphineExperimental treatment 3 interventions
Group B: Thoracic epidural analgesiaActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Cumulative 72-hour volume of intravenous fluids and blood products administered

Intraoperative plus cumulative postoperative intravenous (IV) fluid volume administered, total (mL) = sum of volumes of IV crystalloid, IV colloid, and non-albumin blood products (packed red blood cells \[pRBC\], fresh-frozen plasma \[FFP\], and platelets) administered

Time frame
Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier
2

Area under the curve over 72 hours of the summed pain intensity difference scores at rest (AUC-SPID-PAR_0-72h)

Numerical Rating Scale (NRS) Summed Pain Intensity Difference at rest (SPID-PAR) (calculated as Area Under the Curve \[AUC\] using the trapezoidal rule) over 0 to 72 hours (AUC-SPID-PAR\_0-72h) after surgery. Pain intensity (PI) is assessed preoperatively and at 2, 6-12, 24, 36, 48, 60, and 72 hours after surgery or until hospital discharge, whichever came first, using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is the "worst possible pain". Pain intensity difference (PID\_t) is calculated as the difference in pain intensity from time 0 to each time point t. SPID\_t is calculated using the trapezoidal rule as the area under the curve (AUC) for Pain Intensity Difference over the time interval 0 to t hours, respectively, divided by the length of the time interval (t hours). A positive value is a decrease (improvement) of the pain.

Time frame
72 hours after surgery or until hospital discharge, whichever occurs earlier
3

Cumulative 72-hour opioid consumption (OC_0-72h)

Total perioperative epidural, intravenous, and oral opioid requirements measured in oral morphine equivalents (OME, mg).

Time frame
Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier

Secondary outcomes

1

Vasopressor-free days to day 30

Vasopressor-free days to 30 days after surgery will be defined as the number of days alive and not on vasopressors before 30 days. If the patient is on vasopressors at day 30 or dies prior to day 30, vasopressor-free days will be 0.

Time frame
During index hospital admission (censored at the earliest of hospital discharge, in-hospital death, or 30 days postoperatively)
2

Cumulative intraoperative vasopressor and/or inotrope consumption

Cumulative norepinephrine (NE)-equivalent time-weighted dose (mcg·kg-¹·min-¹ of anesthesia time) of vasopressors and/or inotropes (phenylephrine, norepinephrine, dopamine, and/or epinephrine).

Time frame
Intraoperatively (from anesthesia start time to anesthesia end time)
3

Cumulative perioperative vasopressor and/or inotrope consumption

Cumulative norepinephrine (NE)-equivalent time-weighted dose (mcg·kg-¹·min-¹ of vasopressor and/or inotrope infusion duration) of vasopressors and/or inotropes (phenylephrine, norepinephrine, dopamine, and/or epinephrine).

Time frame
Intraoperatively and during the first 7 days after surgery or until hospital discharge, whichever occurs earlier
4

Cumulative 72-hour volume of intravenous fluids administered

Intraoperative plus cumulative postoperative intravenous (IV) fluid volume administered, excluding non-albumin blood products, total (mL) = sum of volumes of IV crystalloid and IV colloid administered

Time frame
Intraoperatively and during the first 72 hours postoperatively

Other outcomes

1

Cumulative 24-hour volume of intravenous fluids and blood products administered

Intraoperative plus cumulative postoperative intravenous (IV) fluid volume administered, total (mL) = sum of volumes of IV crystalloid, IV colloid, and non-albumin blood products (packed red blood cells \[pRBC\], fresh-frozen plasma \[FFP\], and platelets) administered

Time frame
Intraoperatively and during the first 24 hours postoperatively
2

Area under the curve (AUC) over 24 hours of the summed pain intensity difference (SPID) scores at rest (AUC-SPID-PAR_0-24h)

Numerical Rating Scale (NRS) Summed Pain Intensity Difference at rest (SPID-PAR) (calculated as Area Under the Curve \[AUC\] using the trapezoidal rule) over 0 to 24 hours (AUC-SPID-PAR\_0-24h) after surgery

Time frame
24 hours after surgery
3

Cumulative 24-hour (IV) opioid consumption (OC_0-24h)

Total perioperative epidural, intravenous, and oral opioid requirements measured in oral morphine equivalents (OME, mg).

Time frame
Intraoperatively and during the first 24 hours postoperatively or until hospital discharge, whichever occurs earlier
4

Time to first parenteral opioid dose administration (min)

Parenteral opioid administration is defined as receipt of fentanyl, morphine, and/or hydromorphone via the intravenous (IV) route, either via patient-controlled analgesia (PCA) or nurse/physician administration.

Time frame
72 hours after surgery or until hospital discharge, whichever occurs earlier

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Source ClinicalTrials.gov
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