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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05885230
Enrollment
138
Registered
2023-06-01
Start date
2023-05-01
Completion date
2027-05-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Brief summary

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

PROCEDUREpecto 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.

DRUGlidocaine 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.

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total dose of morphine in the first 24 h postoperatively.24 hours postoperativetotal morphine consumed in the first 24 hour

Secondary

MeasureTime frameDescription
NRS numerical rating scale.24 hours post operativeNRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS\< 4 is acceptable for pain relief
chronic postoperative pain in 3 months after operation according to numerical rating scalewithin 3 months postoperativeNRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS\< 4 is acceptable for pain relief
Time to rescue analgesicwithin 24 hour postoperativetime from extubation to the time the patiants given analgesia
time to extubationwithin 24 hour post operativefrom end of surgery to the time of extubation
length of intensive care staywithin one weekfrom end of surgery to the time of discharging to the surgical word

Countries

Egypt

Contacts

CONTACTMariana A soliman, lecturer
mrmrsyk4@gmail.com01222960009
PRINCIPAL_INVESTIGATORMariana A mansour, Lecturer

benisuef university hospital,Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026