- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232979
M-TAPA Block for Analgesia After Open-Heart Surgery
The Effectiveness of the Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) on Postoperative Analgesia and Recovery in Open-Heart Surgery: A Prospective, Double-Blind, Randomized Controlled Trial
Postoperative pain following open-heart surgery is primarily caused by median sternotomy, although additional contributors include costovertebral joint stress related to sternal retraction and the presence of chest wall and mediastinal drains during the postoperative period. This pain is often severe, especially in the early postoperative hours, making effective management both challenging and essential. Insufficient pain control frequently necessitates high doses of opioids, which may lead to adverse effects such as nausea, vomiting, respiratory complications, and postoperative delirium. Excessive use of anesthetic agents or opioids can also delay extubation and prolong the process of weaning from mechanical ventilation.
The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a regional anesthesia technique performed beneath the costal margin between the internal oblique and transversus abdominis muscles. It provides broad dermatomal coverage, extending approximately from the upper thoracic to the lower thoracic and upper lumbar segments. This study aims to evaluate the postoperative analgesic effectiveness of combining the M-TAPA block with a parasternal block in patients undergoing open-heart surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain following open-heart surgery is primarily caused by median sternotomy, although additional contributors include costovertebral joint stress related to sternal retraction and the presence of chest wall and mediastinal drains during the postoperative period. This pain is often severe, especially in the early postoperative hours, making effective management both challenging and essential. Insufficient pain control frequently necessitates high doses of opioids, which may lead to adverse effects such as nausea, vomiting, respiratory complications, and postoperative delirium. Excessive use of anesthetic agents or opioids can also delay extubation and prolong the process of weaning from mechanical ventilation.
The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a regional anesthesia technique performed beneath the costal margin between the internal oblique and transversus abdominis muscles. It provides broad dermatomal coverage, extending approximately from the upper thoracic to the lower thoracic and upper lumbar segments. This study aims to evaluate the postoperative analgesic effectiveness of combining the M-TAPA block with a parasternal block in patients undergoing open-heart surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: emre ulusoy
- Phone Number: +905379492799
- Email: emreulusoy36@gmail.com
Study Contact Backup
- Name: Eralp Çevikkalp
- Phone Number: +905054554875
- Email: eralpcevikkalp@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 to 85 years with ASA physical status II-III who are scheduled to undergo elective open-heart surgery will be included.
Exclusion Criteria:
Patients who refuse to participate in the study
Patients with coagulopathy
Patients with a history of allergy or toxicity to local anesthetics
Patients with hepatic or renal failure
Patients with uncontrolled diabetes mellitus
Patients with uncontrolled hypertension
Mentally disabled patients
Patients receiving chronic pain therapy (opioid use)
Patients using antidepressant medications
Patients with neuropathic pain
Patients with infection at the injection site
Pregnant, suspected pregnant, or breastfeeding women
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 |
|---|---|
|
Active Comparator: Group M-TAPA
The M-TAPA and parasternal blocks will be administered before surgery.
|
In the M-TAPA group, the block will be performed preoperatively with the patient in the supine position under ultrasound guidance using a high-frequency linear probe (GE ML6-15-D Matrix Linear, Boston, USA) and an 80-mm block needle (Stimuplex Ultra®, Braun, Melsungen, Germany).
After identifying the appropriate plane between the transversus abdominis muscle and the lower surface of the costal cartilage, 5 mL of saline will be injected to confirm correct placement.
Subsequently, 20 mL of 0.25% bupivacaine will be injected bilaterally (a total of 40 mL for both sides).
Before intubation, the block will be performed under aseptic conditions using a high-frequency ultrasound probe (GE ML6-15-D Matrix Linear, Boston, USA) placed immediately lateral to the sternum after identifying the second to fourth intercostal spaces.
An 80-mm echogenic block needle (Stimuplex Ultra®, Braun, Melsungen, Germany) will then be advanced using an in-plane approach from the skin toward the plane between the pectoralis major and intercostal muscles.
A total of 10 mL of 0.25% bupivacaine will be injected bilaterally.
|
|
Active Comparator: Group Control
Preoperatively, a parasternal block and local anesthetic infiltration at the chest tube insertion sites will be administered to all patients.
|
Before intubation, the block will be performed under aseptic conditions using a high-frequency ultrasound probe (GE ML6-15-D Matrix Linear, Boston, USA) placed immediately lateral to the sternum after identifying the second to fourth intercostal spaces.
An 80-mm echogenic block needle (Stimuplex Ultra®, Braun, Melsungen, Germany) will then be advanced using an in-plane approach from the skin toward the plane between the pectoralis major and intercostal muscles.
A total of 10 mL of 0.25% bupivacaine will be injected bilaterally.
Local anesthetic infiltration (10 mL of 0.25% bupivacaine) will be administered around the chest tube and mediastinal drain sites.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
opioid consumption
Time Frame: 0, 2, 4, 8, 16 and 24 hours
|
Fentanyl will be prepared at a concentration of 10 µg/mL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 µg.
|
0, 2, 4, 8, 16 and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Time Frame: 0, 2, 4, 8, 16 and 24 hours
|
Postoperative 24 hours period.
Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
|
0, 2, 4, 8, 16 and 24 hours
|
|
Global recovery scoring system (patient satisfaction scale)- QoR-15
Time Frame: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
|
Researchers will use the Turkish version of the Quality Improvement Survey/QoR-15.
PART A: Participants will be asked by researchers how they felt in the last 24 hours.(0
to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10.
Having a feeling of general well-being PART B Participants will be asked by the researchers whether they have experienced any of the following in the last 24 hours.
(10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) 11.
Moderate pain 12. Severe pain 13.
Nausea or vomiting 14.
Feeling worried or anxious 15.
Feeling sad or depressed
|
The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- Bursa City Hospital 002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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