Back to resultsEffects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transversus thoracic plane block
Pecto intercostal fascial block
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring TTPB, PIFB
Eligibility Criteria
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.
Sites / Locations
- Benisuef University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transversus thoracic muscle plane block
Pecto-intercostal fascial plane block
Arm Description
TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle 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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05627869
Brief Title
Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
TTPB, PIFB
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transversus thoracic muscle plane block
Arm Type
Active Comparator
Arm Description
TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.
Arm Title
Pecto-intercostal fascial plane block
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Transversus thoracic plane block
Other Intervention Name(s)
sunnypivacaine
Intervention Description
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
Intervention Name(s)
Pecto intercostal fascial block
Other Intervention Name(s)
sunnypivacaine
Intervention Description
PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.
Primary Outcome Measure Information:
Title
The primary outcome will be total morphine consumption
Description
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).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The secondary outcomes will be the first analgesic request time
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana A Mansour, lecturer
Phone
01222960009
Email
mrmrsyk4@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana A Mansour, Lecturer
Organizational Affiliation
Benisuef university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benisuef University Hospital
City
Benisuef
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
مريانة عبد السيد سليمان, MD
Phone
01222960009
Email
mrmrsyk4@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
TITLE
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Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.
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