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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05199922
Other study ID # Medipol Hospital 24
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2022
Est. completion date July 20, 2022

Study information

Verified date July 2022
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in several abdominal surgeries.


Description:

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in several abdominal surgeries. In this study, we aimed to evaluate the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic inguinal hernia repair surgery. Our primary aim is to compare the postoperative pain scores (NRS), and our secondary aim is to compare the postoperative rescue analgesic use and postoperative opioid consumption, and the side effects (allergic reaction, nausea, vomiting) associated with opioid use.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 20, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) classification I-II - Scheduled for laparoscopic inguinal hernia repair surgery under general anesthesia Exclusion Criteria: - Bleeding diathesis - Receiving anticoagulant treatment - Known local anesthetics and opioid allergy - Infection of the skin at the site of the needle puncture - Pregnancy or lactation - Patients who do not accept the procedure

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
M TAPA block
Under aseptic conditions, a high frequency linear probe will be placed on the costochondral angle in the sagittal plane. Then the probe will be slightly angled deeply to visualize the lower view of the perichondrium. We will perform M-TAPA with totally 40 ml (20 ml for each side) of %0,25 bupivacaine.

Locations

Country Name City State
Turkey Istanbul Medipol University Hospital Istanbul Bagcilar

Sponsors (1)

Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Altiparmak B, Toker MK, Uysal AI, Turan M, Demirbilek SG. Reply to Tulgar et al.: Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:150-151. doi: 10.1016/j.jclinane.2018.12.005. Epub 2018 Dec 12. — View Citation

Tulgar S, Selvi O, Thomas DT, Deveci U, Özer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. — View Citation

Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Global recovery scoring system (patient satisfaction scale) This scoring system includes evaluating emotional state (12 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (12 questions), and pain (7 questions). Change from baseline score at postoperative 24 hour
Secondary The use of rescue analgesia Tramodol using Postoperative 24 hours period
Secondary Postoperative pain scores Change from Baseline Pain Scores at Postoperative 24 hours. Postoperative 24 hours period
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