Thoracic Paravertebral Block Versus IV Fentanyl Infusion

Postoperative Pain Clinical Trial

Official title:

Bilateral Continous Thoracic Paravertebral Block Versus IV Fentanyl Infusion For Perioperative Analgesia in Patients Undergoing Cardiac Surgery Through Median Sternotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03903367
• Other study ID #: Beni-Suef Hospital
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2019
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Beni-Suef University
• Contact: Samaa ak Rashwan, MD
• Phone: 020120159125
• Email: samakassemrashwan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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).

Locations

Country	Name	City	State
Egypt	Beni-Suef University Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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