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Completed

NCT Number: NCT05476510

M-Tapa vs OSTAP for Laparoscopic Inguinal Hernia Repair Surgery

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

About this study

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.

Postoperative pain is acute pain accompanied by an inflammatory process due to surgical trauma and gradually decreases with tissue healing. Postoperative pain is a serious problem that reduces patient comfort and delays the patient's return to work after surgery. Successful postoperative analgesia occurs in the patient due to pain; It is a known fact that it prevents many of the effects such as being unable to breathe easily and delayed mobilization.

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 the abdominal lateral wall and may be an opioid-sparing strategy that provides a satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia in the abdominal region at the T5-T11 level. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen under US guidance. With the cephalocaudal spread of the local anesthetic solution, analgesia occurs in several dermatomes. In the literature, there are studies investigating the effectiveness of M-TAPA block for postoperative pain management in bariatric surgery.

Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) is one of the body blocks used especially for postoperative analgesia. OSTAP, which Hebbard defined in 2010, is a subcostal version of the Transversus abdominis plane block (TAP block) and is based on the injection of local anesthetic from the lower edge of the costal margin, obliquely between the obliquus externus and Transversus abdominis muscles. OSTAP; Although it is frequently used in laparoscopic abdominal surgery, it is a very difficult block to implement. There are studies reporting that it provides successful analgesia after various abdominal surgeries.

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), the side effects associated with opioid use (allergic reaction, nausea, vomiting), and patient satisfaction (Likert scale).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative management

Drug

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.

Primary outcomes

  1. Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)

    Time frame: Postoperative 24 hours period

    NRS at postoperative 0th hour

Secondary outcomes

  1. The use of rescue analgesia

    Time frame: Postoperative 24 hours period

    Tramodol using

  2. Patient satisfaction scale (seven item likert scale; extremely dissatisfied, mostly dissatisfied, somewhat dissatisfied, neutral, somewhat satisfied, mostly satisfied, extremely satisfied)

    Time frame: Postoperative 24 hours period

    This scoring system includes evaluating the satisfaction level of patient

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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