- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417462
Transversus Thoracic Muscle Plane Block Versus Pectointercostal Fascial Block for Enhanced Recovery After Cardiac Surgery
Transversus Thoracic Muscle Plane Block Versus Pectointercostal Fascial Block for Enhanced Recovery After Cardiac Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.
The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noha H Abdelghany, MD
- Phone Number: +966545945924
- Email: nohadaghash@gmail.com
Study Locations
-
-
-
Asyut, Egypt, 71515
- Recruiting
- Assiut University
-
Contact:
- Noha H Abdelghany, MD
- Phone Number: +966545945924
- Email: nohadaghash@gmail.com
-
Principal Investigator:
- Abdelrahman H Mohammed, MD
-
Principal Investigator:
- Ahmed S Imbaby, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 40 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI) < 35 kg/m2.
- Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).
Exclusion Criteria:
- Valve replacement procedures.
- Emergency operations.
- Redo surgeries.
- Minimally invasive approaches.
- The presence of psychiatric disorders.
- Cognitive impairment preventing accurate assessment using the verbal numerical rating scale (NRS).
- Known hypersensitivity or a history of allergy to local anesthetics.
- Had severe major organ dysfunction.
- Left ventricular ejection fraction below 30%.
- Pregnancy or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group PIFB
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
|
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
|
|
Experimental: Group TTPB
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
|
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
|
|
Sham Comparator: Control Group
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected.
Only 25 saline will be injected superficially.
|
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected.
Only 25 saline will be injected superficially.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total amount analgesic requirement
Time Frame: 24 hours postoperatively
|
In cases where rescue analgesia is required [numerical rating scale (NRS) ≥4], intravenous Nalbuphine 0.1 mg/kg will be given.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Degree of pain will be assessed using Numerical rating scale (NRS) from 0 (no pain) to 10 (worst severe pain).
NRS will be measured at 2h, 4h, 8h, 16h and 24h after surgery.
|
24 hours postoperatively
|
|
The number of patients required rescue analgesia
Time Frame: 24 hours postoperatively
|
The number of patients requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.
|
24 hours postoperatively
|
|
Postoperative nausea and vomiting (PONV)
Time Frame: 24 hours postoperatively
|
The patients will be verbally evaluated according to a descriptive five-point postoperative nausea and vomiting (PONV) scale at 0, 3, 6, 12, 18, and 24 hours after the extubation.
If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required.
The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
|
24 hours postoperatively
|
|
Time to extubation
Time Frame: 24 hours postoperatively
|
After the operation, the time until the patient is extubated will be recorded.
|
24 hours postoperatively
|
|
Length of stay in the intensive care unit.
Time Frame: Average 7 days postoperatively
|
The time from admission to the intensive care unit (ICU) to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days.
Total duration of stay in ICU will be recorded.
|
Average 7 days postoperatively
|
|
Assessment of Delirium
Time Frame: 24 hours postoperatively
|
Delirium will be assessed using the 3-minute diagnostic Confusion Assessment Method (CAM) (acute, inattention, disorganized thinking , altered of consciousness).
The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. Delirium using the 3-minute diagnostic Confusion Assessment Method ( acute , inattention, disorganized thinking , altered of consciousness).
The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. It will be evaluated 24 hrs after extubation.
|
24 hours postoperatively
|
|
Level of patient satisfaction
Time Frame: 24 hours postoperatively
|
Level of patient satisfaction estimated by a 5-point Likert scale (1:extremely dissatisfied; 2: unsatisfied; 3: neutral; 4: satisfied; 5: extremely satisfied).
|
24 hours postoperatively
|
|
Incidence of complications.
Time Frame: 7 days postoperatively
|
Any complications-directly related to the block or the drug used in the block- will be recorded.
Complications can include local anesthetic toxicity, vascular injury, pneumothorax, failed block, and anaphylactic shock.
|
7 days postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2026-300789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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