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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Procedure: pecto intercostal fascial block using bupivacaine 0.25%
* Drug: lidocaine infusion


Participation Criteria
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Eligibility Criteria
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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). obstructive sleep apnea syndrom. coexisting hematologic disorders. pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PIFB group<br>patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side. | Procedure: pecto intercostal fascial block using bupivacaine 0.25%<br>* patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.<br>* Other names: Sunnypivacaine;|
| Active Comparator: LIDOCAINE group<br>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. | Drug: lidocaine infusion<br>* 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.<br>* Other names: Lignocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of morphine in the first 24 h postoperatively. | total morphine consumed in the first 24 hour | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS numerical rating scale. | NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief | 24 hours post operative | 
| chronic postoperative pain in 3 and/or 6 months after operation according to numerical rating scale | NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief | within 3 to 6 months postoperative | 
| Time to rescue analgesic | time from extubation to the time the patiants given analgesia | within 24 hour postoperative | 
| time to extubation | from end of surgery to the time of extubation | within 24 hour post operative | 
| length of intensive care stay | from end of surgery to the time of discharging to the surgical word | within one week |