Recruiting

Epidural vs. Paravertebral

Sponsor:

Dr. Anthony Ho

Code:

NCT02909322

Conditions

Pain Control After Elective Hepatectomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine and Hydromorphone

Ropivacaine and Hydromorphone

Study Details

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

Study ID

NCT02909322

Start date

Apr, 2016

Status verified date

Dec, 2022

Completion date

Mar, 2023

Anticipated

Primary completion date

Mar, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Continuous Epidural Analgesia

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

experimental: Paravertebral Block Analgesia

Analgesic medications will be given via the paravertebral space.

Interventions

Bupivacaine and Hydromorphone

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

Ropivacaine and Hydromorphone

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

Primary outcome measure

  • Opioid consumption [ Time Frame: 0-72 hours after surgery ]
  • Time to first request for opioids [ Time Frame: 0-72 hours after surgery ]
  • Pain scores [ Time Frame: 30min, 4, 8, 24, 48, and 72 hours after surgery ]

Central Contacts and Locations

Central contacts

Locations

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L2V7

Contacts

Debbie DuMerton Shore, RN

613-548-7827shored@kgh.kari.net

Principal Investigator:

Anthony Ho, MD

More Information

Sponsor

Dr. Anthony Ho

Last update posted

Dec 5, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Anthony Ho on 2022-12-05.