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Thoracic Paravertebral Block Versus IV Fentanyl Infusion

B

Beni-Suef University

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Postoperative Pain

Treatments

Drug: Fentanyl Citrate

Study type

Interventional

Funder types

Other

Identifiers

NCT03903367
Beni-Suef Hospital

Details and patient eligibility

About

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

Full 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).

Enrollment

44 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

control
Active Comparator group
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).
Treatment:
Drug: Fentanyl Citrate
paravertebral block
Active Comparator group
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.
Treatment:
Drug: Fentanyl Citrate

Trial contacts and locations

1

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Central trial contact

Samaa ak Rashwan, MD

Data sourced from clinicaltrials.gov

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