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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885230
• Other study ID #: FMBSUREC/09042023/Mikhael
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Beni-Suef University
• Contact: Mariana A soliman, lecturer
• Phone: 01222960009
• Email: mrmrsyk4[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-thoracotomy pain syndrome (PTPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after thoracotomy 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 PTPS .

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 PTPS

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
Egypt	Benisuef University Hospital	Bani Suwayf	e\EYGPT

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of morphine in the first 24 h postoperatively.	total morphine consumed in the first 24 hour	24 hours postoperative
Secondary	NRS numerical rating scale.	NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief	24 hours post operative
Secondary	chronic postoperative pain in 3 months after operation according to numerical rating scale	NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief	within 3 months postoperative
Secondary	Time to rescue analgesic	time from extubation to the time the patiants given analgesia	within 24 hour postoperative
Secondary	time to extubation	from end of surgery to the time of extubation	within 24 hour post operative
Secondary	length of intensive care stay	from end of surgery to the time of discharging to the surgical word	within one week