Erector Spinae Plane Block and Low-Flow Anaesthesia in Laparoscopic Cholecystectomy

Официальное название

Evaluation of the Effects of Preoperative Erector Spinae Plane Block Combined With Low-Flow Anaesthesia on Postoperative Quality of Recovery and Opioid Consumption: A Prospective, Randomized, Controlled Study

Обзор

This prospective randomized controlled study aims to evaluate the effects of preoperative ultrasound-guided erector spinae plane (ESP) block combined with low-flow anaesthesia on postoperative quality of recovery and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The study will compare postoperative recovery quality, pain scores, analgesic requirements, and perioperative outcomes between patients receiving ESP block with low-flow anaesthesia and those receiving standard anaesthetic management.

Подробное описание

Laparoscopic cholecystectomy, despite its minimally invasive nature, is associated with significant postoperative pain. This pain originates from multiple mechanisms, including somatic pain related to trocar insertion sites, visceral pain caused by gallbladder bed manipulation, and referred shoulder pain secondary to diaphragmatic irritation. Due to this heterogeneous pain profile, single-modality analgesic approaches are often insufficient, making multimodal analgesia strategies necessary.

Patient-centered outcome measures have become increasingly important in the evaluation of postoperative recovery. The Quality of Recovery-15 (QoR-15) score is a validated recovery assessment tool that evaluates not only pain but also physical comfort, emotional state, physical independence, and overall patient satisfaction. Therefore, QoR-15 is considered a clinically meaningful primary outcome measure in anaesthesia research.

Ultrasound-guided erector spinae plane (ESP) block is a modern regional anaesthesia technique that provides analgesia through cranio-caudal spread of local anaesthetic within the fascial plane deep to the erector spinae muscle, affecting both dorsal and ventral spinal rami. When performed at thoracic levels, particularly between T6 and T9, ESP block may provide effective somatic and visceral analgesia for laparoscopic cholecystectomy.

Previous randomized controlled studies have demonstrated that ESP block reduces postoperative pain scores, opioid consumption, and postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Furthermore, recent studies have shown improved postoperative recovery quality assessed by QoR-15 scores in patients receiving ESP block.

Low-flow anaesthesia is a modern inhalational anaesthesia technique based on reducing fresh gas flow and rebreathing exhaled gases. This approach decreases volatile anaesthetic consumption, improves cost-effectiveness, and reduces environmental impact. In addition, low-flow anaesthesia may provide physiological advantages such as preservation of airway humidity and temperature, improved mucociliary function, and maintenance of respiratory stability.

Several clinical studies have demonstrated the safety and physiological benefits of low-flow anaesthesia, including reduced volatile anaesthetic consumption while maintaining hemodynamic stability and adequate anaesthetic depth.

Although both ESP block and low-flow anaesthesia have individually been shown to provide beneficial perioperative effects, there is currently no prospective controlled study evaluating the combined effects of these two approaches on postoperative recovery quality and opioid consumption in laparoscopic cholecystectomy patients.

This prospective randomized controlled study aims to evaluate whether the combination of preoperative ultrasound-guided ESP block and low-flow anaesthesia improves postoperative quality of recovery and reduces opioid requirements in patients undergoing elective laparoscopic cholecystectomy.

Вмешательства

• Процедура Erector Spinae Plane Block
  Bilateral ultrasound-guided erector spinae plane block (ESPB) will be performed preoperatively at the T7-T8 level
• Другое Low Fresh Gas Flow (0.5 L/min)
  Low-flow anaesthesia will be maintained with sevoflurane using a fresh gas flow rate of 0.5 L/min after the initial high-flow phase following induction of general anaesthesia.
• Другое Standard Fresh Gas Flow (3 L/min)
  Standard-flow anaesthesia will be maintained with sevoflurane using a fresh gas flow rate of 3 L/min throughout the maintenance phase of general anaesthesia.
• Препарат Bupivacaine
  Bupivacaine 0.25% will be administered bilaterally during ultrasound-guided erector spinae plane block at the T7-T8 level, with 20 mL injected on each side approximately 30 minutes before surgery.
• Препарат Sevoflurane
  Sevoflurane will be used as the inhalational anaesthetic agent for maintenance of general anaesthesia during elective laparoscopic cholecystectomy. The fresh gas flow rate during maintenance will be determined according to study group allocation.

Первичные конечные точки

• Quality of Recovery-15 (QoR-15) Score at Postoperative 24 Hours [Срок оценки: Postoperative 24 hours]

Вторичные конечные точки (5)

• Numeric Rating Scale (NRS) Pain Score [Срок оценки: PACU, 2, 6, 12, and 24 hours postoperatively]
• Postoperative Shoulder Pain Score [Срок оценки: 24 hours postoperatively]
• Total Opioid Consumption During the First 24 Postoperative Hours [Срок оценки: 24 hours postoperatively]
• Time to First Rescue Analgesic Requirement [Срок оценки: 24 hours postoperatively]
• Incidence of Postoperative Nausea and Vomiting (PONV) [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

• Patients aged 18-65 years
• ASA physical status I-II
• Body mass index (BMI) <35 kg/m²
• Scheduled for elective laparoscopic cholecystectomy
• Ability to provide written informed consent

Критерии исключения

• Coagulopathy or bleeding disorders
• Allergy to local anaesthetic agents
• Infection at the block application site
• Neurological or psychiatric disorders
• Communication difficulties
• Chronic opioid or analgesic use
• Reoperation cases
• Acute cholecystitis
• Conversion to open surgery
• Inadequate dermatomal block after ESPB
• Severe intraoperative hemodynamic instability
• Intraoperative blood loss ≥250 mL
• Development of allergic reactions or major complications during follow-up

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

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Taksim Training and Research Hospital — Istanbul

Публикации

• Doger C, Kahveci K, Ornek D, But A, Aksoy M, Gokcinar D, Katar D. Effects of Low-Flow Sevoflurane Anesthesia on Pulmonary Functions in Patients Undergoing Laparoscopic Abdominal Surgery. Biomed Res Int. 2016;2016:3068467. doi: 10.1155/2016/3068467. Epub 2016 Jun 20. PMID 27413741
• Kutlusoy S, Koca E, Aydin A. Reliability of low-flow anesthesia procedures in patients undergoing laparoscopic cholecystectomy: Their effects on our costs and ecological balance. Niger J Clin Pract. 2022 Nov;25(11):1911-1917. doi: 10.4103/njcp.njcp_387_22. PMID 36412300
• Saleem SZ, Akhtar SMM, Fareed A, Shaik AA, Asghar MS. Redefining pain management: investigating the efficacy and safety of erector spinae plane block and oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy - a meta analysis of randomized controlled trials. BMC Anesthesiol. 2025 Apr 16;25(1):182. doi: 10.1186/s12871-025-03059-1. PMID 40240902
• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b. PMID 23411725

Идентификаторы

NCT: NCT07653490 · E-48670771-514.99-311790631

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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