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

Pain Clinical Trial

Official title:

Comparison of Effects of Transversus Thoracic Muscle Plane Block vs Pecto-intercostal Fascial Block on Postoperative Opioid Consumption in Patients Undergoing Open Cardiac Surgery: A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627869
• Other study ID #: Mariana AbdElsayed
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 2023

Study information

• Verified date: July 2023
• Source: Beni-Suef University
• Contact: Mariana A Mansour, lecturer
• Phone: 01222960009
• Email: mrmrsyk4[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• 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 syndrome.

12. Coexisting hematologic disorders.

13. Pregnancy or breastfeeding.

Related Conditions & MeSH terms

• Pain
• Postoperative

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Benisuef University Hospital	Benisuef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be total morphine consumption	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).	24 hours
Secondary	The secondary outcomes will be the first analgesic request time	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.	24 hours