EXORA vs ESP Blocks in Laparoscopic Cholecystectomy

Официальное название

The Analgesic Efficacy of EXORA Block Versus Erector Spinae Plane Block in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia

Обзор

Laparoscopic cholecystectomy is still considered the gold standard for the surgical management of gallbladder disease due to its minimally invasive nature, shorter recovery time, and reduced postoperative complications. Despite these advantages, patients frequently experience moderate to severe postoperative pain, particularly in the early postoperative period, which can impede recovery, delay mobilization, and increase opioid consumption. Excessive opioid use after laparoscopic cholecystectomy is associated with several drawbacks, including nausea, vomiting, sedation, and delayed recovery. It also increases the risk of respiratory depression, especially in vulnerable patients, and may contribute to long-term opioid dependence. These risks highlight the importance of opioid-sparing strategies such as regional anesthesia techniques to improve patient outcomes and enhance recovery. Regional anesthesia techniques have emerged as essential components of multimodal analgesia strategies in abdominal surgeries. Among them, the Erector Spinae Plane (ESP) Block has gained popularity due to its relative ease of administration and favorable safety profile. Recently, a novel fascial plane block known as the EXORA block has been introduced as a promising alternative for abdominal wall analgesia. This block, which targets a different anatomical plane, is postulated to provide comparable or superior analgesic efficacy to traditional methods while maintaining safety and simplicity in execution. Given the ongoing pursuit of optimal analgesia with minimal side effects, it is essential to compare emerging techniques, such as the EXORA block, with established methods like the ESP block. The authors hypothesize that the EXORA and the ESP blocks provide superior postoperative analgesia compared to controls in patients undergoing laparoscopic cholecystectomy and that the EXORA block analgesic profile is superior to that of the ESP block.

Подробное описание

Following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement, this prospective, randomized, double-blinded, controlled clinical trial will be conducted at Fayoum University Hospital (FUH) starting from October 2025 until the sample size is reached.

After obtaining approval from the local institutional ethics committee at Fayoum University Hospital (FUH) and registering the trial on ClinicalTrials.gov, all patients scheduled for elective cholecystectomy at FUH will sign a detailed informed consent form after fulfilling the eligibility criteria.

Patients will be randomly assigned to three equal groups with an allocation ratio of 1:1:1 (n=35) using computer-generated random numbers that will be sealed in a closed opaque envelope, opened by the anesthesiologist responsible for administering the ultrasound-guided block preoperatively

* Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks. * Group B (ESP Block Group): Patients will receive bilateral ESP blocks. * Group C (Control Group): patients will not receive any block, only standard care.

Preoperatively, all patients will be assessed and investigated by complete blood count, Prothrombin time and concentration, kidney and liver functions. Additional investigations, such as serum electrolytes, ECG, ECHO, etc., will be ordered upon individual patient assessment.

All blocks will be performed by an anesthesiologist experienced in regional blocks preoperatively in a separate block room under strict aseptic conditions using ultrasound guidance after applying standard monitoring (pulse oximetry, non-invasive blood pressure, and electrocardiogram) and administering a sedative dose of intravenous midazolam (0.03 mg/kg).

For both groups A and B, sensory block will be assessed by a blinded anesthesiologist after 30 minutes from the block maneuver bilaterally from the distribution of the fifth Thoracic dermatome (T5) down to the level of the twelfth thoracic dermatome (T12). This will be accomplished using a pinprick with a blunt 20-G needle on a two-point scale, where 0 indicates the presence of sensation and 1 indicates numbness or absence of sensation in reference to sensation in the shoulder region. If no sensory loss is observed, the patient will be excluded from the study.

All patients will then be transferred to the operating room, handed over to the attending anesthesiologist who is blinded to group allocation and is responsible for further patient management. standard monitoring will be reapplied, and then general anesthesia will be induced using propofol (2 mg/kg), atracurium (0.5 mg/kg), and fentanyl (2 μg/kg). Anesthesia will be maintained with intermittent intravenous atracurium (0.1 mg/kg boluses) and an isoflurane inhalation in an oxygen and air mixture. An intravenous Ketorolac (30 mg), Nalbuphine (10 mg), and Ondansetron 8 mg will be administered approximately 30 minutes before the end of the operation.

After discharge to the ward, paracetamol 1g /8 hours and ketorolac 30 mg/12 hours will be administered to all patients. Both static (at rest) and dynamic (with movement) visual analogue scale (VAS) will be assessed at 1,2, 4, 6, 12, and 24 hours (where 0 denotes no pain, and 10 represents the most intense pain ever experienced), and if the VAS score is equal to or higher than 4, a rescue analgesic dose of nalbuphine 5 mg will be administered.

Вмешательства

• Процедура EXORA block
  in a supine position, a linear Ultrasound probe (L6-12 RS linear array transducer (6-12 MHz) on GE Healthcare Logiq P7, made in Korea) will be sagittally applied at the parasternal line, lateral to the sternum and xiphoid process. The probe will be manipulated craniocaudally to identify the 6th, 7th, and 8th costal cartilages. At the level of the 8th costal cartilage, a transverse orientation will be used to visualize the rectus abdominis muscle and the costal cartilage beneath. An 88-mm, 22-gau
• Процедура Erector Spinae Plane block
  in a right lateral position, the linear Ultrasound probe will be placed vertically 3 cm lateral to the midline at the level of the 7th thoracic spinal process, identifying the T7 transverse process, and the overlying erector spinae (ES) muscle. An 88-mm, 22-gauge needle will be advanced craniocaudally in-plane until hitting the T7 transverse process. After using hydro-dissection with 4 ml of isotonic saline to confirm the correct needle position, 25 ml of 0.25% bupivacaine will be administered b

Первичные конечные точки

• Total opioid consumption [Срок оценки: Up to 24 hours after surgery]

Вторичные конечные точки (9)

• Intraoperative Fentanyl consumption [Срок оценки: From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours]
• Time needed to complete the block [Срок оценки: From start of block procedure up to 1 hour]
• Sensory block distribution level (pin-prick test) [Срок оценки: after 30 minuets from the block maneuver bilaterally]
• Heart rate [Срок оценки: Upon arrival to Operating Room until 24 hours postoperative]
• Blood pressure [Срок оценки: Upon arrival to Operating Room until 24 hours postoperative]
• Postoperative pain scores by Visual Analogue Scale (VAS) [Срок оценки: From patient discharge to postoperative anesthesia care unit 24 hours postoperatively]
• Rescue analgesia [Срок оценки: Upon recovery from General anesthesia up to 24 h postoperatively]
• Incidence of opioid-related side effects [Срок оценки: From induction of anesthesia up to 24 h postoperatively]
• Incidence of Block-related side effects [Срок оценки: From the time just after giving the block up to 24 h postoperatively]

Критерии участия

Критерии включения

• Elective laparoscopic cholecystectomy
• ASA physical status I-III

Критерии исключения

• Known allergy to local anesthetics
• Chronic pain or regular opioid use
• Coagulopathy or anticoagulant therapy
• Local infection at the block site
• BMI more than 35 kg/m2
• Neurological or psychiatric disorders
• Refusal to participate

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Fayoum University hospital — El Fayoum Qesm

Публикации

• Asad U, Wang CF, Jones MW. Laparoscopic Cholecystectomy. 2025 Jul 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448145/ PMID 28846328
• Roy DK, Sheikh R. A Systematic Review and Meta-Analysis of the Outcomes of Laparoscopic Cholecystectomy Compared to the Open Procedure in Patients with Gallbladder Disease. Avicenna J Med. 2024 Feb 1;14(1):3-21. doi: 10.1055/s-0043-1777710. eCollection 2024 Jan. PMID 38694141
• Ekstein P, Szold A, Sagie B, Werbin N, Klausner JM, Weinbroum AA. Laparoscopic surgery may be associated with severe pain and high analgesia requirements in the immediate postoperative period. Ann Surg. 2006 Jan;243(1):41-6. doi: 10.1097/01.sla.0000193806.81428.6f. PMID 16371735
• Dua A, Aziz A, Desai SS, McMaster J, Kuy S. National Trends in the Adoption of Laparoscopic Cholecystectomy over 7 Years in the United States and Impact of Laparoscopic Approaches Stratified by Age. Minim Invasive Surg. 2014;2014:635461. doi: 10.1155/2014/635461. Epub 2014 Mar 20. PMID 24790759
• Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22. PMID 33493688
• Lohmoller K, Carstensen V, Pogatzki-Zahn EM, Freys SM, Weibel S, Schnabel A. Regional anaesthesia for postoperative pain management following laparoscopic, visceral, non-oncological surgery a systematic review and meta-analysis. Surg Endosc. 2024 Apr;38(4):1844-1866. doi: 10.1007/s00464-023-10667-w. Epub 2024 Feb 2. PMID 38307961
• Sethi D, Garg G. Evaluation of postoperative analgesia of erector spinae plane block in elective laparoscopic cholecystectomy: a randomized controlled trial. Turk J Anaesthesiol Reanim. 2021 Dec;49(6):432-438. doi: 10.5152/TJAR.2021.878. PMID 35110021
• Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6. PMID 30851501

Идентификаторы

NCT: NCT07187310 · M829

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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