Efficacy of Ultrasound Guided PIFB Versus Lidocaine Infusion on Postoperative Pain After Thoracotomy

Beni-Suef University

Status: Enrolling

Conditions: Cardiac Surgery

Treatments: Procedure: pecto intercostal fascial block using bupivacaine 0.25%; Drug: lidocaine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05885230

FMBSUREC/09042023/Mikhael

Details and patient eligibility

About

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 .

Full 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

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. emergency surgery.
2. off-pump surgery.
3. redo surgery.
4. ejection fraction less than 35%.
5. refusal of the patient.
6. known hypersensitivity to LA.
7. chronic opioid use or chronic pain patient.
8. psychiatric problems or communication difficulties.
9. liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
10. renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
11. obstructive sleep apnea syndrom.
12. coexisting hematologic disorders.
13. pregnancy or breastfeeding.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

PIFB group

Active Comparator group

Description:

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

Treatment:

Procedure: pecto intercostal fascial block using bupivacaine 0.25%

LIDOCAINE group

Active Comparator group

Description:

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.

Treatment:

Drug: lidocaine infusion