- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903367
Thoracic Paravertebral Block Versus IV Fentanyl Infusion
Bilateral Continous Thoracic Paravertebral Block Versus IV Fentanyl Infusion For Perioperative Analgesia in Patients Undergoing Cardiac Surgery Through Median Sternotomy
Study Overview
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Banī Suwayf, Egypt
- Recruiting
- Beni-suef university Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- Beni-suef Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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