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NCT Number: NCT05885230

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

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 .

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Key information

Conditions

Cardiac Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benisuef University Hospital

Banī Suwayf, e\EYGPT, Egypt

Location status: Recruiting

Location contact

Mariana A Soliman, MD

CONTACT

[email protected]

01222960009

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pecto intercostal fascial block using bupivacaine 0.25%

Procedure

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

Other names: Sunnypivacaine

Lidocaine infusion

Drug

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

Primary outcomes

  1. 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

  1. NRS numerical rating scale.

    Time frame: 24 hours post operative

    NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief

  2. chronic postoperative pain in 3 months after operation according to numerical rating scale

    Time frame: within 3 months postoperative

    NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief

  3. Time to rescue analgesic

    Time frame: within 24 hour postoperative

    time from extubation to the time the patiants given analgesia

  4. time to extubation

    Time frame: within 24 hour post operative

    from end of surgery to the time of extubation

  5. length of intensive care stay

    Time frame: within one week

    from end of surgery to the time of discharging to the surgical word

Study contacts

Contact information is provided by the study sponsor or research team.

Mariana A soliman, lecturer

CONTACT

[email protected]

01222960009

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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