Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair

Официальное название

Evaluation of the Effectiveness of Transversalis Fascia Plane Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair

Обзор

Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. The block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair. This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Подробное описание

Inguinal hernia repairs are one of the most common general surgical operations and are generally performed with laparoscopic technique. Even laparoscopic inguinal hernia repair results in less acute postoperative pain compared to the open technique, untreated early pain may prolong hospital stay, exacerbate general discomfort, and affect the length of recovery, which may also have social and -economic implications. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications, postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.

Transversalis Fascia Plane Block (TFPB) is a body block that blocks the T12-L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall Its positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open technique inguinal hernia repair.

This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Вмешательства

• Процедура Transversalis Fascia Plane Block
  After the wound closure is completed and the patient is still under general anesthesia the TFPB will be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed longitudinally, 2-3 cm laterally, just above the iliac crest at the mid-axillary line. After the external oblique, internal oblique, and transversus abdominis muscles are distinguished, the common aponeurosis of
• Процедура Post Operative Pain Management
  Acetaminophen 1 gr (Paracerol, Polifarma®) intravenous (IV), and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be administered to all patients 30 minutes before wound closure. After surgery, Acetaminophen (Paracerol, Polifarma®) 1 gr IV, and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be given three times a day. Another anesthesiologist will assess patients after surgery. If the patient's pain score (NRS) is 4 or higher, IV pethidine (Aldolan, Liba Laboratory ®) 0,5 mg/kg will be giv
• Процедура Port Site Infiltration
  A total of 20 ml of 0.25% bupivacaine ( (Buvicaine, Polifarma ®) will be applied to the trocar entry points by the surgeon at the beginning of the operation, before entering the trocars.

Первичные конечные точки

• Rescue analgesic use [Срок оценки: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.]

Вторичные конечные точки (2)

• Compare postoperative pain scores (NRS scores) [Срок оценки: NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.]
• Side effects and complications [Срок оценки: Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively]

Критерии участия

Критерии включения

• American Society of Anesthesiologists (ASA) classification I- II Patients
• Unilateral Inguinal Hernia Repair Surgery
• Elective Operations

Критерии исключения

• Patients with a history of chronic pain
• Evidence of infection in the intervention area
• Allergy to local anesthetics
• Coagulopathy
• Body-mass index (BMI) ≥ 30
• Body weight ≤ 50 kg
• Patients who do not agree 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 Mega Hospital Complex — Istanbul

Публикации

• Celik HK, Tulgar S, Buk OF, Koc K, Unal M, Genc C, Suren M. Comparison of the analgesic efficacy of the ultrasound-guided transversalis fascia plane block and erector spinae plane block in patients undergoing open inguinal hernia repair under spinal anesthesia. Korean J Anesthesiol. 2024 Apr;77(2):255-264. doi: 10.4097/kja.23404. Epub 2024 Jan 8. PMID 38185619
• Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22. PMID 39039833
• Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available. PMID 19495909
• Xu LS, Li Q, Wang Y, Wang JW, Wang S, Wu CW, Cao TT, Xia YB, Huang XX, Xu L. Current status and progress of laparoscopic inguinal hernia repair: A review. Medicine (Baltimore). 2023 Aug 4;102(31):e34554. doi: 10.1097/MD.0000000000034554. PMID 37543778
• Tolver MA, Rosenberg J, Bisgaard T. Early pain after laparoscopic inguinal hernia repair. A qualitative systematic review. Acta Anaesthesiol Scand. 2012 May;56(5):549-57. doi: 10.1111/j.1399-6576.2011.02633.x. Epub 2012 Jan 19. PMID 22260427

Идентификаторы

NCT: NCT06778629 · Medipol Hospital 5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗