Ultrasound-Guided Regional Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy

Официальное название

Comparison of the Effectiveness of Ultrasound-Guided Recto-Intercostal Fascial Plane Block and Transversus Abdominis Plane Block in Postoperative Analgesia Management of Patients Undergoing Laparoscopic Cholecystectomy

Обзор

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery. Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy. This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.

Подробное описание

Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Postoperative pain after laparoscopic cholecystectomy is multifactorial and may result from trocar site incisions, visceral manipulation, peritoneal irritation, and diaphragmatic stimulation due to pneumoperitoneum. Various analgesic strategies, including systemic opioids, non-opioid analgesics, local anesthetic infiltration, and regional anesthesia techniques, are used to manage postoperative pain in these patients.

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described regional anesthesia technique that provides analgesia to the sternal, epigastric, and upper-mid abdominal regions by targeting the fascial plane between the rectus abdominis muscle and the costal cartilage. RIFPB provides sensory blockade at the T6-T10/11 dermatomal levels and has been reported to be effective for postoperative analgesia in thoracic and upper abdominal procedures. Due to its anatomical spread and mechanism of action, RIFPB may offer effective analgesia following laparoscopic cholecystectomy.

Ultrasound-guided transversus abdominis plane block (TAPB) is a well-established regional anesthesia technique performed by injecting local anesthetic between the internal oblique and transversus abdominis muscles. TAPB provides analgesia to the anterolateral abdominal wall at the T6-L1 dermatomal levels and is commonly used for postoperative pain control after various abdominal surgeries, including laparoscopic cholecystectomy.

In this study, the investigators aim to compare the effectiveness of US-guided RIFPB and TAPB for postoperative pain management after laparoscopic cholecystectomy and to compare both techniques with a control group.

Вмешательства

• Процедура Recto-Intercostal Fascial Plane Block
  The block will be performed under general anesthesia immediately before extubation, with the patient in the supine position under ultrasound guidance (Vivid Q). After aseptic preparation, a high-frequency linear probe (11-12 MHz) covered with a sterile sheath and an 80-mm block needle (Braun 360°) will be used. The probe will be positioned to identify the xiphoid process, rectus abdominis muscle, and sixth costal cartilage. Using an in-plane technique, the needle will be advanced in a caudal-to-
• Процедура Transversus- Abdominis Plane Block
  The transversus abdominis plane block will be performed immediately after completion of surgery and before extubation, with the patient in the supine position under ultrasound guidance( Vivid Q). Following aseptic preparation, a high-frequency linear probe (11-12 MHz) and an 80-mm block needle (Braun 360°) will be used to identify the abdominal wall muscle layers at the anterior axillary line between the 12th rib and the iliac crest. Using an in-plane technique, the needle will be advanced into
• Другое Post-operative Pain Management
  Thirty minutes before the end of surgery, all patients will receive the standard postoperative analgesia regimen consisting of intravenous ibuprofen 400 mg (Intrafen®) and intravenous tramadol 100 mg (Contramal®). Postoperative patient assessment will be performed by an anesthesiologist who is not involved in the intervention.If the patient's NRS score is ≥4 at any time point, intravenous meperidine (Aldolan®) at a dose of 0.5 mg/kg will be administered as rescue analgesia.

Первичные конечные точки

• Opioid consumption [Срок оценки: During the first 24 hours postoperatively]

Вторичные конечные точки (3)

• Postoperative pain scores [Срок оценки: Postoperative hours 1, 3, 6, 12, 18, and 24.]
• Adverse events [Срок оценки: During the first 24 hours postoperatively]
• Postoperative Rescue Analgesic Consumption: [Срок оценки: During the first 24 hours postoperatively]

Критерии участия

Критерии включения

• ASA physical status I-II
• Scheduled for elective laparoscopic cholecystectomy

Критерии исключения

• Known allergy to local anesthetics or opioid medications
• Infection at the planned block site
• History of alcohol or drug dependence
• Use of anticoagulant therapy
• Refusal to participate in the study

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol University — Istanbul

Публикации

• Ciftci B, Omur B, Alver S, Akin AN, Yildiz Y, Tulgar S. The Medipol Combination: Novel Rectointercostal Fascial Plane Block and Pectointercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery: A Report of 15 Cases. A A Pract. 2024 Jun 5;18(6):e01794. doi: 10.1213/XAA.0000000000001794. eCollection 2024 Jun 1. PMID 38836555
• Dost B, Turunc E, Ozdemir E. Subxiphoid Pericardial Window Using a Combination of Rectointercostal Fascial Plane Block and Superficial Parasternal Intercostal Plane Block. J Cardiothorac Vasc Anesth. 2024 May;38(5):1282-1283. doi: 10.1053/j.jvca.2024.02.002. Epub 2024 Feb 4. No abstract available. PMID 38453556
• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31. PMID 29226150
• Brogi E, Kazan R, Cyr S, Giunta F, Hemmerling TM. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials. Can J Anaesth. 2016 Oct;63(10):1184-1196. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15. PMID 27307177
• El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17. PMID 19376789

Идентификаторы

NCT: NCT07321639 · Medipol Hospital 7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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