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

NCT ID: NCT05885230

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-31

Brief 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 .

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 PTPS

Conditions

Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PIFB group

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

Group Type: ACTIVE_COMPARATOR

pecto intercostal fascial block using bupivacaine 0.25%

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

lidocaine infusion

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Sunnypivacaine; Lignocaine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mariana Soliman

Lecturer of anaesthesia, surgical intensive care and pain managment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana A mansour, Lecturer

Role: PRINCIPAL_INVESTIGATOR

benisuef university hospital,Egypt

Locations

Benisuef University Hospital

Banī Suwayf, e\EYGPT, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mariana A soliman, lecturer

Role: CONTACT

mrmrsyk4@gmail.com

01222960009

Facility Contacts

Mariana A Soliman, MD

Role: primary

mrmrsyk4@gmail.com

01222960009

Other Identifiers

FMBSUREC/09042023/Mikhael

Identifier Type: -

Identifier Source: org_study_id