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Thoracic Paravertebral Block Versus IV Fentanyl Infusion

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ClinicalTrials.gov Identifier: NCT03903367
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Samaa Rashwan, Beni-Suef University

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date April 4, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Critical-Care Pain Observation Tool [ Time Frame: Critical-Care Pain Observation Tool (CPOT) will be assessed 1 hour after admitting the patient to the ICU, as base line reacord then every 4 hoursfor 24 hours ]
The aim of this study is to compare the efficacy of continuous bilateral thoracic paravertebral block and IV fentanyl infusion on perioperative pain in patients subjected to conventional cardiac surgery through median sternotomy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracic Paravertebral Block Versus IV Fentanyl Infusion
Official Title  ICMJE Bilateral Continous Thoracic Paravertebral Block Versus IV Fentanyl Infusion For Perioperative Analgesia in Patients Undergoing Cardiac Surgery Through Median Sternotomy
Brief Summary High-quality analgesia during and following cardiac surgery is infrequently obtained, Sternotomy and thoracotomy is associated with significant pain that resulte in hypoventilation, atelectasis, and hypoxemia,Pain management is rarley a priority in the immediate postoperative care of these patients, who frequently require mechanical ventilation in an intensive care environment
Detailed Description

Paravertebral nerve blocks (PVBs) can provide excellent intraoperative anaesthetic and postoperative analgesic conditions with less side effects and fewer contraindications than central neural blocks,Bilateral PVB has been successfully used in the thoracic, abdominal, and pelvic regions(12). Paravertebral analgesia is produced by placing local anaesthetic (LA) alongside the vertebral column, close to the exit of the spinal nerves(13)..

Traditionally, profound intraoperative analgesia has been provided by using high doses of opioids to suppress hormonal and metabolic stress responses to surgical stimuli. This regimen resulted in improved morbidity and mortality after cardiac surgery(14).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE Drug: Fentanyl Citrate
standard GA and receive fentanyl infusion 2 mcg/kg/h after tracheal intubation and stopped at the end of the operation ,When HR or MBP increased ≥20% from base line readings, incremental dose of fentanyl will be given (2mcg /kg).
Other Name: fentanyl
Study Arms  ICMJE
  • Active Comparator: control
    standard GA and receive fentanyl infusion 2 mcg/kg/h after tracheal intubation and stopped at the end of the operation ,When HR or MBP increased ≥20% from base line readings, incremental dose of fentanyl will be given (2mcg /kg).
    Intervention: Drug: Fentanyl Citrate
  • Active Comparator: paravertebral block
    Bilateral thoracic paraverteberal catheters will be inserted preoperative at level of T4 in order to block thoracic dermatomal levels from T3-T7 and 0.3ml/kg 0.25% bupivacaine bouls dose in each catheter maximum 20 ml in each catheter before induction and testing sensation bilaterally by pinprick and ice after 15-20min from injection then standard GA and after tracheal intubation continuous infusion of 0.1 ml /kg/h 0.25% bupivacaine in each catheter and stopped at the end of the operation , When HR or MBP increased ≥20% from base line readings, increamental dose of fentanyl will be given (2mcg /kg), the catheters will be removed after 24 h.
    Intervention: Drug: Fentanyl Citrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • males and females patients scheduled for elective open heart surgery

Exclusion Criteria:

  • Patients with chest trauma, injuries to peripheries, unstable hemodynamics, sensitivity to local anesthetic drugs, infection at the operation site, renal or hepatic dysfunction, left ventricular dysfunction, coagulation abnormalities and patients on opioids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samaa ak Rashwan, MD 020120159125 samakassemrashwan@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03903367
Other Study ID Numbers  ICMJE Beni-Suef Hospital
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samaa Rashwan, Beni-Suef University
Study Sponsor  ICMJE Beni-Suef University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samaa ak Rashwan, MD Assisstant proffesor of anesthesia
PRS Account Beni-Suef University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP