Clinical trial

Comparison of the Efficacy of US-guided M-Tapa Block vs OSTAP for Postoperative Analgesia in Patients After Laparoscopic Inguinal Hernia Repair Surgery

Name
Medipol Hospital 29
Description
Inguinal hernia repair is the most common of abdominal surgical procedures and is usually performed laparoscopically. Many factors play a role in the pain that develops after surgery and is generally considered to be visceral pain. Phrenic nerve irritation due to CO2 insufflation into the peritoneal cavity, abdominal distention, tissue trauma, sociocultural status, and individual factors are the factors that play a role in the occurrence of this pain. Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a new block that provides effective analgesia in the anterior and lateral thoracoabdominal areas, where 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 abdominal lateral wall and may be an opioid-sparing strategy with satisfactory quality recovery in patients undergoing laparoscopic surgery. Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) is one of the body blocks used especially for postoperative analgesia. OSTAP, defined by Hebbard in 2010, is a subcostal version of the Transversus abdominis plane block (TAP block), based on the injection of local anesthetic from the lower edge of the costal margin, obliquely between the obliquus externus and Transversus abdominis muscles. This study aimed to compare the efficacy of US-guided M-TAPA block and OSTAP block for postoperative analgesia management after laparoscopic inguinal hernia repair surgery. Our primary aim is to compare postoperative pain scores (0. hour NRS), and our secondary aim is to evaluate the use of rescue analgesics (opioids), side effects associated with opioid use (allergic reaction, nausea, vomiting), and patient satisfaction (Likert scale).
Trial arms
Trial start
2022-08-10
Estimated PCD
2023-07-20
Trial end
2023-07-25
Status
Completed
Treatment
Postoperative management
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 100 mg tramadol will be performed for rescue analgesia.
Arms:
Group M-TAPA = M-TAPA Block Group, Group OSTAP = OSTAP Block Group
Size
60
Primary endpoint
Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)
Postoperative 24 hours period
Eligibility criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) classification I-II * Scheduled for laparoscopic inguinal hernia repair surgery under general anesthesia Exclusion Criteria: * Bleeding diathesis * anticoagulant treatment * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic inguinal hernia repair surgery will be included in the study. Patients will be randomly divided into two groups (Group M TAPA = M-TAPA group, Group OSTAP = OSTAP group) including 30 patients each, before entering the operating room.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Outcomes Assessor and participant will be blinded to the stud', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-07-27

1 organization

1 product

1 indication

Organization
Medipol University
Indication
Inguinal Hernia