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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Procedure: pecto intercostal fascial block using bupivacaine 0.25%; Drug: lidocaine infusion

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

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana A soliman, lecturer; Phone Number: 01222960009; Email: mrmrsyk4@gmail.com

Study Locations

• Egypt
  • e\EYGPT
    • Banī Suwayf, e\EYGPT, Egypt
      • Recruiting
      • Benisuef university hospital
      • Contact: Mariana A Soliman, MD; Phone Number: 01222960009; Email: mrmrsyk4@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
chronic postoperative pain in 3 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 months postoperative

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Mariana A mansour, Lecturer, benisuef university hospital,Egypt

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: FMBSUREC/09042023/Mikhael

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No