Epidural Versus Paravertebral Block Analgesia After Hepatectomy

NCT02909322 | Unknown Phase 4

• 1 other identifier: ANAE-270-15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Control After Elective Hepatectomy

Outcome Measures

Primary Outcomes (3)

• Opioid consumption

  Cumulative opioid consumption during the postoperative period will be recorded.

  0-72 hours after surgery

• Time to first request for opioids

  The first time after surgery each participant asks for opioid medication for pain will be recorded.

  0-72 hours after surgery

• Pain scores

  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 Outcomes (14)

• Nausea

  30min, 4, 8, 24, 48, and 72 hours after surgery

• Satisfaction with analgesia

  72 hours after surgery

• Success rates of CEA and PVB

  0-72 hours after surgery

• Failure rates of CEA and PVB

  0-72 hours after surgery

• Mean arterial pressure

  0-72 hours after surgery

Study Arms (2)

Continuous Epidural Analgesia

ACTIVE COMPARATOR

Analgesic medications will be given via epidural, the standard of care.

Procedure: Bupivacaine and Hydromorphone

Paravertebral Block Analgesia

EXPERIMENTAL

Analgesic medications will be given via the paravertebral space.

Procedure: Ropivacaine and Hydromorphone

Interventions

Bupivacaine and Hydromorphone PROCEDURE

Patients receive bupivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.

Continuous Epidural Analgesia

Ropivacaine and Hydromorphone PROCEDURE

Patients receive ropivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.

Paravertebral Block Analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Anthony Ho: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

RECRUITING

Related Publications (50)

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MeSH Terms

Interventions

Bupivacaine; Hydromorphone; Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Anthony MH Ho, MD,FRCPC

  Queen's University/ Kingston Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony MH Ho, MD, FRCPC

CONTACT

613-548-7827; anthony.ho@kingstonhsc.ca

Debbie DuMerton Shore, RN

CONTACT

613-548-7827; deborah.dumerton@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: September 21, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)