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Completed

NCT Number: NCT05502159

M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Cholesistectomy

Ultrasound (US)-guided Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia in the anterior and lateral abdominal walls after laparoscopic surgery, and 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 good quality recovery in patients undergoing laparoscopic surgery.

US-guided External oblique intercostal block (EOB) is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia between T6-T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing M-TAPA and EOB yet.

In this study, our aim is to compare the effectiveness of US-guided M-TAPA block and EOB for postoperative analgesia management after laparoscopic cholecystectomy surgery. Our primary aim is to compare patient recovery scores (QoR15 Turkish version), our secondary aim is to compare postoperative pain scores (24-hour NRS), postoperative rescue analgesic use (opioid), and opioid-related side effects (allergic reaction, nausea, vomiting).

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

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

Cholecystectomy is the most common of the abdominal surgical procedures performed in developed countries and is usually performed laparoscopically. Many factors play a role in the pain that develops after laparoscopic cholecystectomy and is generally considered to be visceral pain. Phrenic nerve irritation as a result of CO2 insufflation into the peritoneal cavity, abdominal distention, tissue trauma, trauma due to the removal of the gallbladder, sociocultural status, and individual factors are the factors that play a role in the emergence of this pain.

Postoperative pain is acute pain that is accompanied by an inflammatory process due to surgical trauma and gradually decreases with tissue healing. Postoperative pain in patients undergoing laparoscopic cholecystectomy 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 not being able 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 abdominal walls after 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 good quality recovery in patients undergoing laparoscopic surgery.

M-TAPA block provides analgesia in the T5-T11 abdominal region. Sonoanatomy is easy to visualize on US and the spread of local anesthetic can be easily seen. With the cephalo-caudal 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 post-operative pain management in bariatric surgery. In the literature, there is no randomized study evaluating the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic cholecystectomy operation.

US-guided External oblique intercostal block (EOB) is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia between T6-T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing M-TAPA and EOB yet.

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 at the site of block
  • Patients who do not accept the procedure

Treatment and study plan

M-TAPA

Drug

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 total of 40 ml (20 ml for each side) of %0,25 bupivacaine.

EOB

Drug

In the supine position, a high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed on the midaxillary line between the spina iliaca anterior superior and the umbilicus. Using the In-Plane technique, 5 ml of saline will be injected under the external oblique muscle of the block needle and the block location will be confirmed. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be administered. The same procedure will be applied to the other side (40 ml of 0.25% bupivacaine in total).

Primary outcomes

  1. Global recovery scoring system (patient satisfaction scale)

    Time frame: Change from baseline score at postoperative 24 hour

    We will use the Turkish version of Quality of Recovery / QoR-15 questionairre

Secondary outcomes

  1. Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

    Time frame: Postoperative 24 hours period (0, 2, 4, 8, 16 ve 24 h)

    Change from Baseline Pain Scores at Postoperative 24 hours.

  2. The use of rescue analgesia

    Time frame: Postoperative 24 hours period

    Meperidin using (Number of Participants and Concentration of Meperidin)

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Comparison of Ultrasound-Guided M-TAPA Block and External Oblique Intercostal Block for Postoperative Analgesia Management in Patients Undergoing Laparoscopic Cholecystectomy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2022
Registry last updated
Jun 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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