Clinical trial

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

Name

Medipol Hospital 35

Description

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).

Trial arms

Trial start

2023-12-20

Estimated PCD

2024-05-10

Trial end

2024-06-20

Status

Recruiting

Treatment

TAPB

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.

Arms:

Group TAPB = Transversus abdominis plane block group

EOIB

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).

Arms:

Group EOIB = External oblique intercostal plane block group

Size

Primary endpoint

Global recovery scoring system (patient satisfaction scale)

Change from baseline score at postoperative 24 hour

Eligibility criteria

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

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 cholecystectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group TAPB = TAP group, Group EOIB = EOB group) including 30 patients each, before entering the operating room.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Outcomes Assessor and participant were blinded to the study', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-03-29

1 organization

2 products

3 indications

Organization

Product

Indication

Indication

Indication

Product