Efficacy of Ultrasound Guided PIFB Versus Lidocaine Infusion on Postoperative Pain After Sternotomy
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pecto intercostal fascial block using bupivacaine 0.25%, lidocaine infusion.
- Who it may be relevant to
- Registry conditions: Cardiac Surgery. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy of Ultrasound-guided Pecto-Intercostal Fascial Plain Block Versus Lidocaine Infusion on Acute and Chronic Post-sternotomy Pain; A Prospective Randomized Controlled Trial
Overview
Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy 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 PSPS .
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 PSPS
Interventions
- 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. - 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.
Primary outcome measures
- Total dose of morphine in the first 24 h postoperatively. [Time frame: 24 hours postoperative]
Secondary outcome measures (5)
- NRS numerical rating scale. [Time frame: 24 hours post operative]
- chronic postoperative pain in 3 months after operation according to numerical rating scale [Time frame: within 3 months postoperative]
- Time to rescue analgesic [Time frame: within 24 hour postoperative]
- time to extubation [Time frame: within 24 hour post operative]
- length of intensive care stay [Time frame: within one week]
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).
- obstructive sleep apnea syndrom.
- coexisting hematologic disorders.
- pregnancy or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Benisuef University Hospital — Banī Suwayf
Identifiers
NCT: NCT05885230 · FMBSUREC/09042023/Mikhael