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Thoracic Paravertebral Block Versus IV Fentanyl Infusion

Sponsor
Beni-Suef University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03903367
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Fentanyl Citrate
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Prevention
Official Title:
Bilateral Continous Thoracic Paravertebral Block Versus IV Fentanyl Infusion For Perioperative Analgesia in Patients Undergoing Cardiac Surgery Through Median Sternotomy
Anticipated Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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).

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 Names:
  • fentanyl

    		•
    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.

    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 Names:
  • fentanyl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Critical-Care Pain Observation Tool [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-Suef University Hospital Banī Suwayf Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Principal Investigator: Samaa ak Rashwan, MD, Assisstant proffesor of anesthesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samaa Rashwan, Samaa Abou Alkassem Rashwan, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT03903367
    Other Study ID Numbers:
    • Beni-Suef Hospital
    First Posted:
    Apr 4, 2019
    Last Update Posted:
    Apr 4, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Fentanyl

    Study Results

    No Results Posted as of Apr 4, 2019