Comparing ultrasound-guided pain relief techniques after heart surgery

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

This study is testing whether a new pain relief method using ultrasound can help heart surgery patients feel less pain after their operation compared to a standard lidocaine treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beni-Suef University (Academic / other)
• Locations: 1 site (Banī Suwayf, e\EYGPT)
• Trial ID: NCT05885230 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of ultrasound-guided Pecto-intercostal Fascial Block (PIFB) versus continuous lidocaine infusion for managing postoperative pain in patients undergoing elective on-pump cardiac surgery with sternotomy. The PIFB technique targets specific nerves to provide localized pain relief, while lidocaine infusion is known for its analgesic and anti-inflammatory properties. The study aims to determine which method better reduces the incidence of post-thoracotomy pain syndrome (PTPS), a common complication after such surgeries.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 scheduled for elective on-pump cardiac surgery with sternotomy.

Not a fit: Patients undergoing emergency or off-pump surgeries, or those with significant comorbidities such as chronic pain or psychiatric issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing cardiac surgery, potentially reducing the prevalence of chronic postoperative pain.

How similar studies have performed: While the PIFB technique is relatively novel, there is emerging evidence supporting the efficacy of similar regional anesthesia techniques in managing postoperative pain, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Banī Suwayf, e\EYGPT

• Benisuef University Hospital — Banī Suwayf, e\EYGPT, Egypt (Recruiting)

Study contacts

• Principal investigator: Mariana A mansour, Lecturer — benisuef university hospital,Egypt
• Study coordinator: Mariana A soliman, lecturer

Conditions Cardiac Surgery