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

NCT ID: NCT05627869

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Pain Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transversus thoracic muscle plane block

TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.

Group Type ACTIVE_COMPARATOR

Transversus thoracic plane block

Intervention Type PROCEDURE

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 plane block

PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.

Group Type ACTIVE_COMPARATOR

Pecto intercostal fascial block

Intervention Type PROCEDURE

PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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sunnypivacaine sunnypivacaine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Mariana Soliman

Lecturer of anaesthesia, surgical intensive care and pain managment

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana A Mansour, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Benisuef university hospital

Locations

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Benisuef University Hospital

Benisuef, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mariana A Mansour, lecturer

Role: CONTACT

01222960009

Facility Contacts

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مريانة عبد السيد سليمان, MD

Role: primary

01222960009

References

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Mansour MA, Mahmoud HE, Fakhry DM, Kassim DY. Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2024 Feb 10;24(1):63. doi: 10.1186/s12871-024-02432-w.

Reference Type DERIVED
PMID: 38341525 (View on PubMed)

Other Identifiers

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Mariana AbdElsayed

Identifier Type: -

Identifier Source: org_study_id

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