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Recruiting
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Comparing Spinal anesthesia with intrathecal with Continuous thoracic epidural analgesia for hepatectomy

Official title: Spinal Anesthesia For Enhanced Recovery After Liver Surgery

Spinal Anesthesia for Enhanced Recovery After Liver Surgery

Condition: HepatectomySponsor: University of ManitobaTarget enrollment: 128
  • 2 groups
  • One site, in Winnipeg
  • Recruiting
University of Manitoba, Winnipeg, Manitoba

Interventions (7)

  • Medical procedure

    Continuous thoracic epidural analgesia

    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

  • Medical procedure

    Spinal anesthesia with intrathecal morphine

    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

  • Medication

    Bupivacaine 0.75% in Dextrose Inj 8.25%

    0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%

Canadian Sites (1)

1 of 1 recruiting

  • University of Manitoba

    Winnipeg, Manitoba

    Recruiting

Eligibility Criteria

See who this study is looking for25 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Body mass index (BMI) between 17 and 40 kg·m-², inclusive;
  • +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;
  • +Stated willingness to comply with all study procedures and availability for the duration of the study
  • +Provision of signed and dated informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • +Stated willingness and ability to comply with all study and/or follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → evaluations and communicate clearly with the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and staff; and
  • +Voluntary participation and ability to provide written informed consent prior to any study procedures.
  • +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;
  • +Negative result on serum pregnancy test at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → and negative urine pregnancy test at BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (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;

Exclusion

  • 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
  • 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
  • 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× baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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;
  • 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.
  • Emergency surgery;
  • 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 siteTrial siteA hospital or clinic where a study is actually run.Read more → 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;
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Morphine, together with one or more of: Spinal anesthesia with intrathecal morphine and Bupivacaine 0.75% in Dextrose Inj 8.25%.

Registry label: A: Intrathecal morphine

Group B, the comparison group, receives one or more of: Continuous thoracic epidural analgesia, Bupivacaine 0.25% Preservative-Free Injectable Solution, Bupicavaine 0.125% epidural solution and Hydromorphone 10 mcg/mL epidural solution.

Registry label: B: Thoracic epidural analgesia

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 128 people.

The study is currently expected to finish around December 2031.

The main measurement is taken over: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Cumulative 72-hour volume of intravenous fluids and blood products administered — measured over Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier.

Area under the curve over 72 hours of the summed pain intensity difference scores at rest (AUC-SPID-PAR_0-72h) — measured over 72 hours after surgery or until hospital discharge, whichever occurs earlier.

Cumulative 72-hour opioid consumption (OC_0-72h) — measured over Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT03715517 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Continuous thoracic epidural analgesiaProcedure

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

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Spinal anesthesia with intrathecal morphineProcedure

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

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Bupivacaine 0.75% in Dextrose Inj 8.25%Drug

0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About MorphineDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Bupivacaine 0.25% Preservative-Free Injectable SolutionDrug

0.25 mg⋅kg-¹ bupivacaine 0.25%

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Bupicavaine 0.125% epidural solutionDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Hydromorphone 10 mcg/mL epidural solutionDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Intraoperatively and during the first 72 hours postoperatively or until hospital discharge, whichever occurs earlier.

The study as a whole is currently expected to finish around 2031-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 128 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Winnipeg, Manitoba, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.