Thoracic Paravertebral Block Versus IV Fentanyl Infusion

NCT ID: NCT03903367

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2019-12-31

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).

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Fentanyl Citrate

Intervention Type: DRUG

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).

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.

Group Type: ACTIVE_COMPARATOR

Fentanyl Citrate

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

fentanyl

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Samaa Rashwan

Samaa Abou Alkassem Rashwan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samaa ak Rashwan, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant proffesor of anesthesia

Locations

Beni-Suef University Hospital

Banī Suwayf, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Samaa ak Rashwan, MD

Role: CONTACT

samakassemrashwan@gmail.com

020120159125

Facility Contacts

Samaa Rashwan, MD

Role: primary

0201270159125

Other Identifiers

Beni-Suef Hospital

Identifier Type: -

Identifier Source: org_study_id