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Completed

NCT Number: NCT06178757

TAP Block vs External Oblique Plane Block for Laparoscopic Cholecystectomy Surgery

Ultrasound (US) guidedTransversus Abdominis Plane Block (TAPB) is performed by injecting a local anesthetic into the plane between the internal oblique and transverse abdominis muscles and provides analgesia in the anterolateral walls of the abdomen after abdominal surgery. Ultrasound-guided TAPB has been commonly used for many years.

US-guided External oblique intercostal block (EOIB) is a novel block performed by injection of local anesthetic between the external and internal oblique muscles at the level of 6th-8th ribs. This block provides abdominal analgesia between T6 and T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing TAPB and EOIB yet.

In this study, we aim to compare the effectiveness of US-guided TAPB and EOIB 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/meperidine), and opioid-related side effects (allergic reaction, nausea, vomiting).

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cholecystitis, Acute Cholecystitis, Chronic Digestive System Diseases Gallbladder Diseases Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract 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 abdominal surgery performed in developed countries and is usually performed laparoscopically. The etiology of pain after laparoscopic cholecystectomy is multifactorial and is generally considered visceral pain. Diaphragmatic nerve irritation due to CO2 insufflation into the peritoneal cavity, abdominal distension, tissue damage, damage due to dissection of the gallbladder, sociocultural situation, and individual factors play a role in the occurrence of this pain..

Postoperative pain is an acute pain that is accompanied by inflammation caused by surgical stress and decreases over time with tissue healing. Pain in the postoperative period in patients undergoing laparoscopic cholecystectomy surgery is a serious problem that reduces patient comfort and delays the patient's return to work after surgery (4). Successful postoperative analgesia management prevents many of the complications such as respiratory problems and delayed mobilization (5).

Transverse Abdominis Plane Block (TAPB), performed under ultrasound (US) guidance, is a block that is performed by injecting a local anesthetic into the plane between the internal oblique and transverse abdominis muscles and provides analgesia in the anterolateral walls of the abdomen after surgery. Ultrasound-guided TAPB is commonly used.

TAPB provides analgesia in the abdominal region in T6-L1 dermatomes. Sonoanatomy is easy to visualize on US and the spread of local anesthetic can be seen. Analgesia occurs in several dermatomes with the cephalo-caudal spread of the local anesthetic solution. Studies are proving that TAP block is effective in some abdominal surgeries such as hysterectomy, cesarean section, cholecystectomy, inguinal hernia and prostatectomy. Sensory block areas formed by TAPB are highly variable and may result in insufficient blocks.

External oblique block (EOIB) performed under US guidance is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia covering the T6-T10 dermatomes. There are studies in the literature proving that it provides effective analgesia (12-14). However, no study comparing TAPB and EOIP has been published yet.

In this study, we aim to compare the effectiveness of US-guided TAPB and EOIB 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/meperidine), and opioid-related side effects (allergic reaction, nausea, vomiting).

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 cholecystectomy surgery under general anesthesia

Exclusion criteria

  • Bleeding diathesis
  • anticoagulant treatment
  • local anesthetics and opioid allergy
  • Infection at the site of the block
  • Patients who do not accept the procedure

Treatment and study plan

TAPB

Drug

As soon as the surgical procedure is completed, TAPB will be applied before extubation. After aseptic conditions are ensured, the 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 at the level of the anterior axillary line between the 12th rib and the iliac crest, and the external oblique abdominal muscle, internal oblique abdominal muscle, and transverse abdominis muscle will be visualized. Then, using the in-plane technique, the needle will be advanced with the help of ultrasound until the needle tip reaches the space between the internal oblique and transversus abdominis muscles. After negative pressure aspiration, 5ml saline will be injected and the block location will be confirmed. Once the block location is confirmed, 20ml 0.25% bupivacaine (40ml total for each side) will be injected bilaterally.

EOIB

Drug

As soon as the surgical procedure is completed, EOIB will be applied before extubation. After aseptic conditions are ensured, the high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath in the supine position, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed on the 6th rib in the mid-axillary line, at the line between the anterior superior iliac spine and the umbilicus. Using the In-Plane technique, 5 ml of saline will be injected between, the external oblique muscle and the rib, and the block location will be confirmed. After confirming the block location, 20 ml 0.25% bupivacaine will be applied to the plane between 6.,7., and 8. ribs and the muscles. The same procedure will be applied to the other side (a total of 40 ml 0.25% bupivacaine).

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

    Change from Baseline Pain Scores at Postoperative 24 hours.

  2. The use of rescue analgesia

    Time frame: Postoperative 24 hours period

    Meperidine using (Number of Participants and Concentration of Meperidine)

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Comparison of Ultrasound-Guided Transversus Abdominis Plane Block (TAP) and External Oblique Plan Block (EOIB) for Postoperative Recovery and Pain Scores After Laparoscopic Cholecystectomy Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2023
Registry last updated
Jul 30, 2024

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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