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Clinical Trials/NCT05885230
NCT05885230
Recruiting
Not Applicable

The Efficacy of Ultrasound-guided Pecto-Intercostal Fascial Plain Block Versus Lidocaine Infusion on Acute and Chronic Post-thoracotomy Pain; A Prospective Randomized Controlled Trial

Beni-Suef University1 site in 1 country138 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
pecto intercostal fascial block using bupivacaine 0.25%
Conditions
Cardiac Surgery
Sponsor
Beni-Suef University
Enrollment
138
Locations
1
Primary Endpoint
Total dose of morphine in the first 24 h postoperatively.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-thoracotomy pain syndrome (PTPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after thoracotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PTPS .

Detailed Description

Ultrasound-guided Pecto-intercostal Fascial Block (PIFB) has been advocated by some researchers for cardiac surgery. Pecto-intercostal fascial plane block (PIFB) is a novel, minimally invasive, regional fascial plane block technique. PIFB was first described by de la Torre in patients undergoing breast surgery . PIFB targets the anterior intercostal nerves as they run in the fascial plane between the pectoral and the intercostal muscles and emerge on either side of the sternum. Also, lidocaine, a short-acting local anesthetic, has been proved to have analgesic and anti-inflammatory effects . The application of lidocaine by continuous infusion in the intraoperative period and immediately after the surgery appears to reduce the immediate postoperative pain, and may prevent the PTPS

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
May 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mariana Soliman

Lecturer of anaesthesia, surgical intensive care and pain managment

Beni-Suef University

Eligibility Criteria

Inclusion Criteria

  • age between 18 and 75 years.
  • patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
  • American Society of Anesthesiologists classification of physical status \< IV.

Exclusion Criteria

  • emergency surgery.
  • off-pump surgery.
  • redo surgery.
  • ejection fraction less than 35%.
  • refusal of the patient.
  • known hypersensitivity to LA.
  • chronic opioid use or chronic pain patient.
  • psychiatric problems or communication difficulties.
  • liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
  • renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min).

Arms & Interventions

PIFB group

patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.

Intervention: pecto intercostal fascial block using bupivacaine 0.25%

LIDOCAINE group

1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery.

Intervention: lidocaine infusion

Outcomes

Primary Outcomes

Total dose of morphine in the first 24 h postoperatively.

Time Frame: 24 hours postoperative

total morphine consumed in the first 24 hour

Secondary Outcomes

  • length of intensive care stay(within one week)
  • NRS numerical rating scale.(24 hours post operative)
  • chronic postoperative pain in 3 months after operation according to numerical rating scale(within 3 months postoperative)
  • Time to rescue analgesic(within 24 hour postoperative)
  • time to extubation(within 24 hour post operative)

Study Sites (1)

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