Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection

NCT01407666 | Completed DMC

• 1 other identifier: MOD09070393-01 / PRO09070393
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized study is intended to assess the efficacy and safety of bilateral continuous paravertebral blocks compared to continuous epidural block for open liver resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in controlling the perioperative pain; and 2) safe, with less frequent complications following open liver resection when compared to continuous epidural block.

Conditions

Liver Disease; Pain

Keywords

paravertebral block; epidural block; pain management; liver resection; comparison

Outcome Measures

Primary Outcomes (1)

• Pain immediately after maximum incentive spirometry

  Pain will be assessed using an 11-point verbal numerical pain scale (VAS) with 0 indicating no pain and 10 indicating the worst pain imaginable;(21) pain will be determined 24 hours postoperatively immediately after maximum incentive spirometry.

  24 hours postoperatively

Secondary Outcomes (1)

• date of the removal of the catheter

  up to one week after the surgery

Study Arms (2)

Bilateral paravertebral blocks

EXPERIMENTAL

Bilateral continuous paravertebral blocks for open liver resection

Procedure: paravertebral blocks

epidural block

NO INTERVENTION

received thoracic epidural block for open liver resection

Interventions

paravertebral blocks PROCEDURE

use bilateral thoracic paravertebral blocks for pain control

Also known as: regional anesthesia

Bilateral paravertebral blocks

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists physical status (ASAPS) I to III patients aged over 18 years and scheduled to undergo elective open liver resection at UPMC Presbyterian/Montefiore Hospital will be screened for enrollment in the study. One hundred (100) patients will be enrolled in this study with equal numbers (n = 50) in each arm of the trial. In order to avoid skewed sex difference between the two groups, the sex will be allocated.

You may not qualify if:

• non elective surgery,
• ASAPS IV or greater,
• age younger than 18 years,
• any contraindication to the placement of an epidural catheter or bilateral paravertebral catheters
• chronic pain conditions
• preoperative opioid use
• coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
• allergy to any of the drugs/agents used our study protocol
• preoperative chronic renal dysfunction, who requires renal replacement therapy or serum creatinine greater than 1.4 mg/dL
• altered mental status (not oriented to place, person, or time),
• any comorbid conditions that, in the judgment of the consulting surgeon or anesthesiologist, would proscribe the patient from any aspect of the study, -
• inability to provide adequate informed consent
• refusal to participate in the study.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Liver Diseases; Pain; Agnosia

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Tetsuro Sakai, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: August 2, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)