Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01407666
First received: February 17, 2011
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Liver Disease
Pain
Procedure: paravertebral blocks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparative Study Between Epidural and Bilateral Paravertebral Blocks for Perioperative Pain Management in Patients Undergoing Open Liver Resection

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Pain immediately after maximum incentive spirometry [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • date of the removal of the catheter [ Time Frame: up to one week after the surgery ] [ Designated as safety issue: Yes ]
    date of the removal of the catheter with any requirement of blood transfusion because of coagulation


Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilateral paravertebral blocks
Bilateral continuous paravertebral blocks for open liver resection
Procedure: paravertebral blocks
use bilateral thoracic paravertebral blocks for pain control
Other Name: regional anesthesia
No Intervention: epidural block
received thoracic epidural block for open liver resection

Detailed Description:

Background: A number of studies evaluating unilateral continuous paravertebral block demonstrate equal or superior analgesia when compared to epidural analgesia for postoperative pain control (1-7). At the same time, these studies show a decreased incidence of side effects and complications, including: hypotension, pulmonary complications, urinary retention, nausea and vomiting and failed blocks. Several studies also indicate that bilateral paravertebral blocks provide adequate postoperative analgesia (8-14). However, no study has been performed to date that shows a direct comparison between epidural and bilateral paravertebral blocks in patients undergoing open liver resection.Objectives: 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.Methods: A hundred adult patients undergoing elective open liver resection will be randomized to receive a continuous epidural block or continuous bilateral paravertebral blocks for perioperative analgesia. The primary outcome will be the degree of pain control measured by visual analog scale at 24 hours post surgery (at rest and while the patient is performing maximum incentive spirometry). The secondary outcomes will include: 1) Assessment of pain (at rest, with cough, and with ambulation) using the verbal numerical pain scale will be performed postoperatively every 8 hours by floor nursing staff until discharge. During the night the patient will not be awakened for pain assessment. 2) Intravenous opioid requirement: In addition to pain score, postoperative intravenous opioid requirements [hydromorphone (mg)] will also be recorded daily; Frequency of side effects and complications; and other functional status (volume of maximum incentive spirometry, time to extubation, total time for initial ambulation, the length of the hospital stay, time to return of bowel function, readiness for discharge from the hospital, and length of hospital stay). At one month post surgery, health-related quality of life, mortality, and any morbidities will be assessed. Each variable will be compared between the paravertebral group and the epidural group to examine the hypotheses above. Clinical Implications: Bilateral continuous paravertebral blocks could be an equally effective and safe alternative to a continuous epidural block for perioperative pain management in patients who undergo open liver resection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407666

Contacts
Contact: Tetsuro Sakai, MD, PhD 412-648-6077 sakait@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Tetsuro Sakai, MD, PhD    412-648-6077    sakait@upmc.edu   
Principal Investigator: Tetsuro Sakai, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Tetsuro Sakai, MD, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Tetsuro Sakai, MD, PhD / Associate Professor, Department of Anesthesiology, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier: NCT01407666     History of Changes
Other Study ID Numbers: MOD09070393-01 / PRO09070393
Study First Received: February 17, 2011
Last Updated: July 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
paravertebral block
epidural block
pain management
liver resection
comparison

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 25, 2014