A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC)

Официальное название

A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC): A Double-Blinded Randomized Comparative Study.

Обзор

Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus it's an economical operation. Nevertheless, it results in moderate to severe pain.(2).By using regional anesthesia techniques to effectively control pain and lessen the requirement for opioid analgesics, ERAS implementation has demonstrated significant decreases in opioid usage and improved overall patient outcomes (3). (4) To minimize the need for opioids, opioid sparing anesthesia employs a multimodal strategy that includes nonsteroidal anti-inflammatory medications, paracetamol, local anesthetics (LA), and, if feasible, regional anesthetic techniques and regional analgesia. (5) With fewer systemic side effects, regional anesthetic techniques-like nerve blocks-offer tailored pain treatment. The best regional pain management strategy for LC surgery is still unknown, though.(4) Modified Thoracoabdominal Nerves Block Through Perichondral Approach (M-TAPA) Block is a new technique defined as a modification of TAPA Block in which local anaesthetics are administered only to the underside of the perichondral surface, creating a sensory block between T5-T12 dermatomes. While the external oblique intercostal plane (EOIPB) block provides blockade of the lateral and anterior cutaneous branches of the intercostal nerves from T6/7 to T10/11.This study aims to compare the efficacy of both MTAPA and EOIPB in patients undergoing LC surgery .

Вмешательства

• Другое Bilateral Ultrasound Guidance M-TAPA
  transversus abdominis, internal oblique, and external oblique muscles will be identified on the costochondral angle in the sagittal plane at the 10th costal margin. deep angle will be given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. The needle will be inserted in the cranial direction using the in-plane technique, and the needle tip will be moved to the posterior aspect of the
• Процедура Bilateral Ultrasound Guidance EOIPB
  The patients will be positioned in the supine position with the ipsilateral arm in abduction. The transducer will be positioned in a cephalad to caudad parasagittal plane at the anterior axillary line at the level of the sixth and seventh ribs in line with the xiphoid process. Using the in-plane technique, the needle will be advanced from cephalad to caudad until the tip lies in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs. Following hy

Первичные конечные точки

• comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS [Срок оценки: . NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period.]

Вторичные конечные точки (8)

• evaluating the quality of recovery via the QOR-40 questionnaire. [Срок оценки: the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU .]
• identifying dermatomal coverage of each block via pinprick test. [Срок оценки: Dermatomal coverage will be tested using pinprick test in PACU after evaluating the QoR-40 within the first hour postoperatively]
• evaluating the efficacy of each block in providing analgesia intraoperatively by measuring amount of fentanyl consumed in micrograms [Срок оценки: intraoperatively]
• Total opioid consumption in the first 24 hours postoperatively in mgs [Срок оценки: postoperatively with a total of 24 hour]
• Time to first mobilization in hours [Срок оценки: postoperatively up to 24 hour]
• Incidence of block-related complications [Срок оценки: postoperatively with a total of 24 hour]
• Incidence of PONV. [Срок оценки: every six hours for a total of 24 hour postoperatively]
• the Time to first rescue opioid [Срок оценки: it will be measured postoperatively for a total period of 24 hour]

Критерии участия

Критерии включения

• Adults aged 18-65 years
• Scheduled for Laparoscopic cholecystectomy surgery
• ASA (American Society of Anaesthesiologists) physical status I-II

Критерии исключения

• Known allergy to local anaesthetics
• Coagulopathy or anticoagulant use
• Infection at the site of block
• Chronic pain conditions
• Advanced liver or kidney failure
• History of abdominal surgery or trauma
• Alcohol or drug use
• Refusal to participate
• Chronic opioid consumption
• Use of painkillers in the preoperative 24hours
• Conversion to open surgery
• Body mass index ( BMI ) > 35

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Faculity of medicine , Kasr Al Aini Hospitals , Cairo University — Cairo

Публикации

• Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4. PMID 36307755

Идентификаторы

NCT: NCT06810206 · MD-462-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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