- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05627869
Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.
July 8, 2023 updated by: Mariana Soliman, Beni-Suef University
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
The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mariana A Mansour, lecturer
- Phone Number: 01222960009
- Email: mrmrsyk4@gmail.com
Study Locations
-
-
-
Benisuef, Egypt
- Recruiting
- Benisuef University Hospital
-
Contact:
- مريانة عبد السيد سليمان, MD
- Phone Number: 01222960009
- Email: mrmrsyk4@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 75 years.
- Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
- American Society of Anesthesiologists classification of physical status < IV.
Exclusion Criteria:
- Emergency surgery.
- Off-pump surgery.
- Redo surgery.
- Ejection fraction less than 35%.
- Refusal of the patient.
- Known hypersensitivity to LA.
- Chronic opioid use or chronic pain patient.
- Psychiatric problems or communication difficulties.
- Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7)
- Renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
- Obstructive sleep apnea syndrome.
- Coexisting hematologic disorders.
- Pregnancy or breastfeeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.
Other Names:
|
Active Comparator: 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.
|
PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome will be total morphine consumption
Time Frame: 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).
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary outcomes will be the first analgesic request time
Time Frame: 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.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mariana A Mansour, Lecturer, Benisuef University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Estimated)
July 1, 2023
Study Completion (Estimated)
July 1, 2023
Study Registration Dates
First Submitted
November 1, 2022
First Submitted That Met QC Criteria
November 23, 2022
First Posted (Actual)
November 28, 2022
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 8, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
TITLE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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