Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.

Not Applicable

Recruiting

• Conditions: Pain; Postoperative
• Interventions: Procedure: Pecto intercostal fascial block; Procedure: Transversus thoracic plane block

• Registration Number: NCT05627869
• Lead Sponsor: Beni-Suef University

Brief Summary

The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.

Detailed Description

Cardiac surgery performed through median sternotomy is associated with significant postoperative pain.Poststernotomy pain leads to decreased patient satisfaction, delirium, cardiovascular complications (hypertension, tachycardia, arrhythmias), hyperglycemia and respiratory complications (bronchial secretion stasis, atelectasis and pneumonia).High-dose opioids can provide good postoperative analgesia for patients undergoing heart surgery. However, opioids have some side effects.The advent of ultrasound-guided regional anaesthesia led to the development of fascial plane chest wall block as transthoracic plane block and pectointercostal fascial block.

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-11-28
• Study Start: 2023-02-01
• Status Verified: 2023-07
• Primary Completion: 2023-07
• Study Completion: 2023-07
• Last Update Submitted: 2023-07-08
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 syndrome.
12. Coexisting hematologic disorders.
13. Pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pecto-intercostal fascial plane block	Pecto intercostal fascial block	PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.
Transversus thoracic muscle plane block	Transversus thoracic plane block	TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.

Primary Outcome Measures

Name	Time	Method
The primary outcome will be total morphine consumption	24 hours	Total morphine consumption within 24 hours according Visual Analogue Score (VAS) for sternal pain both during rest and with cough (ranging from 0 indicating no pain to 10 indicating extreme pain). A score ≤ 3 was considered acceptable for pain relief. Supplementary rescue analgesia was administered in the form of morphine IV 0.05 mg/kg (at VAS ≥ 4).

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes will be the first analgesic request time	24 hours	Is the time to ask for the first postoperative analgesia (morphine), and will be calculated from extubation to patient reporting Visual Analogue Score (VAS) ≥ 4.

Trial Locations

Locations (1)

Benisuef University Hospital; 🇪🇬 Benisuef, Egypt