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

June 18, 2026 updated by: Mariana Soliman, Beni-Suef University

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

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • e\EYGPT
      • Banī Suwayf, e\EYGPT, Egypt
        • Recruiting
        • Benisuef University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 24 hours postoperative
total morphine consumed in the first 24 hour
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours post operative
Time to rescue analgesic
Time Frame: within 24 hour postoperative
time from extubation to the time the patiants given analgesia
within 24 hour postoperative
time to extubation
Time Frame: within 24 hour post operative
from end of surgery to the time of extubation
within 24 hour post operative
length of intensive care stay
Time Frame: within one week
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
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
within 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Mariana A mansour, Lecturer, benisuef university hospital,Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

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)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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