Epidural Versus Paravertebral Block Analgesia After Hepatectomy

December 2, 2022 updated by: Dr. Anthony Ho

Analgesic and Hemodynamic Effects of Continuous Epidural Analgesia Compared to Paravertebral Block in Liver Resection Patients

The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions routinely use continuous epidural analgesia (CEA) for pain control in this patient population. A functioning CEA provides adequate analgesia, but is associated with high failure rates (20-30%) and sometimes significant hemodynamic disturbances (hypotension) requiring an increased amount of intravenous fluid and blood products to maintain homeostasis. Furthermore, its safety has been the subject of debate in liver resection patients due to the elevated risk of epidural hematoma and its serious neurological consequences. These limitations highlight the need to explore other options for analgesic control after hepatectomy, such as paravertebral block (PVB). PVB has been shown to provide similar analgesia with a lower incidence of pulmonary complications, side effects (pruritis, urinary retention, nausea and vomiting, hypotension), and failure rates (6.1%) when compared to CEA in thoracic surgery, and therefore has been suggested as a safer alternative in hepatectomy patients. Despite this, there are no studies comparing the efficacy of CEA and PVB as analgesic techniques after hepatectomy. The investigators propose a randomized controlled trial to compare the analgesic efficacy, side effects, and complications associated with CEA and PVB in patients undergoing elective hepatectomy through a right subcostal incision.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions routinely use continuous epidural analgesia (CEA) for pain control in hepatectomy patients. However, its safety has been the subject of debate. Paravertebral block (PVB) has been suggested as a safer alternative in this patient population. Despite this, there are no studies comparing the efficacy of CEA and PVB as analgesic techniques after hepatectomy. Although CEA provides high quality analgesia, and reduces cardiovascular and respiratory complications and the incidence of postoperative thromboembolic events, it is associated with hypotension and complications such as epidural hematoma, epidural abscess, and spinal cord injury, which are serious concerns in hepatectomy patients. Furthermore, patients given CEA are more likely to need blood transfusions, and transfused patients have significantly higher mortality rates, complications related to infection, and hospital length of stay. PVB is a less popular technique that involves injecting local anesthetic (LA) into the paravertebral space. This technique has been successfully used for pain relief after several surgical procedures, including ablation of hepatic tumours and hepatectomy. Although CEA and PVB have never been compared in hepatectomy patients, they have been compared in thoracotomy patients; in this patient population, PVB and CEA provide similar levels of pain control, but CEA is associated with more complications and side effects such as hypotension, nausea, vomiting, and urinary retention, and PVB is associated with better pulmonary function. Both CEA and PVB are reasonably effective for post-hepatectomy analgesia compared to placebo, and have their own strengths and weaknesses. The gold standard CEA provides excellent analgesia at the expense of more intense hypotension, significant failure rates (20-30%), and a higher risk of epidural hematoma and its serious neurological consequences. These limitations highlight the need to explore other options for analgesic control after hepatectomy such as PVB. Therefore, the investigators propose a randomized controlled trial to compare the analgesic efficacy, hemodynamic changes, and side effects in CEA and PVB in patients undergoing elective hepatectomy through a right subcostal incision. Since CEA is currently the gold standard for analgesia after hepatectomy, the investigators propose a non-inferiority trial to determine whether PVB produces a similar analgesic profile to CEA in hepatectomy patients, while being associated with fewer adverse side effects.

This is a randomized, controlled, pilot study. It will consist of two groups of participants undergoing hepatectomy: those receiving CEA, and those receiving PVB for analgesic control. CEA and PVB protocols will follow the usual standard of care at Kingston General Hospital (KGH). Participants in the CEA group will receive bupivacaine with hydromorphone infusion after induction of general anesthesia for surgery. Participants in the PVB group will receive a bolus dose of ropivacaine, and then ropivacaine infusion after induction of general anesthesia. Upon emergence from anesthesia, all participants will be transferred to the post-anesthetic care unit (PACU). Here, CEA participants will be started on patient-controlled epidural analgesia (PCEA) of bupivacaine and hydromorphone plus a self-administered bolus dose with a lockout period of 30 min if participants require additional pain relief, and PVB participants will be started on a patient-controlled paravertebral analgesia (PCPA) of ropivacaine plus a self-administered bolus dose with a lockout period of 30 min if participants require additional pain relief. All participants will receive oral hydromorphone every 4 hours as required for breakthrough pain relief starting on the morning of the second postoperative day. A member of the research team will assess the presence and severity of pain and nausea during the postoperative period. The assessments will be performed at 30 minutes after arrival to the PACU, and thereafter at 4, 8, 24, 48, and 72 hours after surgery. Investigators will ask all participants to score their pain at rest and with coughing on a numeric rating scale (NRS, where 0=no pain and 10=worst pain imaginable), and nausea scores (0=none, 1=mild, 2=moderate, 3=vomiting) at each of the above listed time points. At 72 hours after surgery, participant satisfaction with regard to analgesia will be assessed (1=very poor, 2=poor, 3=satisfactory, 4=good, 5=excellent). The requirement for breakthrough pain relief, the time of first breakthrough pain relief request, and cumulative opioid consumption will be recorded during the postoperative 72 hours.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L2V7
        • Recruiting
        • Kingston General Hospital
        • Contact:
        • Principal Investigator:
          • Anthony Ho, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years of age
  • ASA I-III
  • Undergoing elective liver resection through right subcostal incision
  • Proficient in English
  • Competent to give consent

Exclusion Criteria:

  • Not given informed consent
  • Not competent to give informed consent
  • Dementia or neurological impairment
  • Jaundice (bilirubin > 50μmol/L)
  • Liver resection combined with secondary surgical procedure
  • Contraindication to either epidural or paravertebral block (INR ≥ 1.6, platelet count < 100,000/mm3, fever, previous back surgery)
  • Anticipated significant coagulopathy post-liver resection (as indicated by a Model for End-Stage Liver Disease score >8 or predicted liver resection of more than 500g)
  • Contraindications to any of the study medications
  • Remain intubated in the postoperative period, due to inability to assess pain scores
  • Midline incision and/or any type of extended incision that is not restricted to the standard right subcostal incision
  • Body mass index < 18 or > 40
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Epidural Analgesia
Analgesic medications will be given via epidural, the standard of care.
Procedure: Bupivacaine and Hydromorphone
Patients receive bupivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.
Experimental: Paravertebral Block Analgesia
Analgesic medications will be given via the paravertebral space.
Procedure: Ropivacaine and Hydromorphone
Patients receive ropivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 0-72 hours after surgery
Cumulative opioid consumption during the postoperative period will be recorded.
0-72 hours after surgery
Time to first request for opioids
Time Frame: 0-72 hours after surgery
The first time after surgery each participant asks for opioid medication for pain will be recorded.
0-72 hours after surgery
Pain scores
Time Frame: 30min, 4, 8, 24, 48, and 72 hours after surgery
At the specified time points, participants will rate their pain on a scale from 0 to 10.
30min, 4, 8, 24, 48, and 72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea
Time Frame: 30min, 4, 8, 24, 48, and 72 hours after surgery
At the specified time points, participants will rate their nausea.
30min, 4, 8, 24, 48, and 72 hours after surgery
Satisfaction with analgesia
Time Frame: 72 hours after surgery
Participants will rate their satisfaction with their analgesia.
72 hours after surgery
Success rates of CEA and PVB
Time Frame: 0-72 hours after surgery
The number of successful CEA and PVB procedures will be recorded.
0-72 hours after surgery
Failure rates of CEA and PVB
Time Frame: 0-72 hours after surgery
The number of therapeutic failures of CEA and PVB procedures will be recorded.
0-72 hours after surgery
Mean arterial pressure
Time Frame: 0-72 hours after surgery
Mean arterial pressure will be recorded.
0-72 hours after surgery
Central venous pressure
Time Frame: 0-72 hours after surgery
Central venous pressure will be recorded.
0-72 hours after surgery
Urine output
Time Frame: 0-72 hours after surgery
Urine output will be recorded.
0-72 hours after surgery
Acid-base
Time Frame: 0-72 hours after surgery
pH, bicarbonate, partial pressure of carbon dioxide, and partial pressure of oxygen in the blood will be recorded.
0-72 hours after surgery
Intravenous fluid volume
Time Frame: 0-72 hours after surgery
Total volume of crystalloids, colloids, and blood products given perioperatively and during the 72 hours after surgery will be recorded.
0-72 hours after surgery
Vasopressor volume
Time Frame: 0-72 hours after surgery
Total volume of vasopressors given perioperatively and during the 72 hours after surgery will be recorded.
0-72 hours after surgery
Resumption of full oral diet
Time Frame: 0-72 hours after surgery
The number of days taken to resume a full oral diet will be recorded.
0-72 hours after surgery
Hospital length of stay
Time Frame: 0-72 hours after surgery
The number of days until participants are discharged will be recorded.
0-72 hours after surgery
Adverse events
Time Frame: 0-72 hours after surgery
Any postoperative adverse events will be recorded.
0-72 hours after surgery
Demographic data
Time Frame: Upon enrollment up to 72 hours after surgery
Descriptive demographic data will be recorded.
Upon enrollment up to 72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Anthony Ho

Investigators

  • Principal Investigator: Anthony MH Ho, MD,FRCPC, Queen's University/ Kingston Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANAE-270-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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