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Thoracic Paravertebral Block Versus IV Fentanyl Infusion

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl Citrate
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beni-Suef University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

control

paravertebral block

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Critical-Care Pain Observation Tool
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

Secondary Outcome Measures

Full Information

First Posted
April 1, 2019
Last Updated
April 3, 2019
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT03903367
Brief Title
Thoracic Paravertebral Block Versus IV Fentanyl Infusion
Official Title
Bilateral Continous Thoracic Paravertebral Block Versus IV Fentanyl Infusion For Perioperative Analgesia in Patients Undergoing Cardiac Surgery Through Median Sternotomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
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).
Arm Title
paravertebral block
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Fentanyl Citrate
Other Intervention Name(s)
fentanyl
Intervention Description
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).
Primary Outcome Measure Information:
Title
Critical-Care Pain Observation Tool
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samaa ak Rashwan, MD
Phone
020120159125
Email
samakassemrashwan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samaa ak Rashwan, MD
Organizational Affiliation
Assisstant proffesor of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-Suef University Hospital
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samaa Rashwan, MD
Phone
0201270159125

12. IPD Sharing Statement

Plan to Share IPD
No

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Thoracic Paravertebral Block Versus IV Fentanyl Infusion

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