Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection
Tracking Information | |||||
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First Received Date ICMJE | February 17, 2011 | ||||
Last Updated Date | July 29, 2011 | ||||
Start Date ICMJE | August 2010 | ||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01407666 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection | ||||
Official Title ICMJE | Prospective Randomized Comparative Study Between Epidural and Bilateral Paravertebral Blocks for Perioperative Pain Management in Patients Undergoing Open Liver Resection | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: paravertebral blocks
use bilateral thoracic paravertebral blocks for pain control
Other Name: regional anesthesia |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 100 | ||||
Estimated Completion Date | July 2013 | ||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01407666 | ||||
Other Study ID Numbers ICMJE | MOD09070393-01 / PRO09070393 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Tetsuro Sakai, MD, PhD / Associate Professor, Department of Anesthesiology, University of Pittsburgh School of Medicine | ||||
Study Sponsor ICMJE | University of Pittsburgh | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of Pittsburgh | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |