- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07653490
Erector Spinae Plane Block and Low-Flow Anaesthesia in Laparoscopic Cholecystectomy
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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Leyla Sivacigil, MD
- Telefonní číslo: 90 5065983478
- E-mail: veralleyla@hotmail.com
Studijní záloha kontaktů
- Jméno: Celal Kaya, MD
- Telefonní číslo: 90 5435176760
- E-mail: celalmadime@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: ESPB + Standard-Flow Anaesthesia
Participants will receive a preoperative bilateral ultrasound-guided ESPB with 20 mL of 0.25% bupivacaine on each side at the T7-T8 level, in addition to standard-flow sevoflurane anaesthesia during elective laparoscopic cholecystectomy.
Fresh gas flow will be maintained at 3 L/min during the maintenance phase of anaesthesia.
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Bilateral ultrasound-guided erector spinae plane block (ESPB) will be performed preoperatively at the T7-T8 level
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.
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.
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.
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Experimentální: ESPB + Low-Flow Anaesthesia
Participants will receive a preoperative bilateral ultrasound-guided ESPB with 20 mL of 0.25% bupivacaine on each side at the T7-T8 level, in addition to low-flow sevoflurane anaesthesia during elective laparoscopic cholecystectomy.
Following induction, fresh gas flow will be reduced to 0.5 L/min during the maintenance phase of anaesthesia.
|
Bilateral ultrasound-guided erector spinae plane block (ESPB) will be performed preoperatively at the T7-T8 level
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.
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.
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of Recovery-15 (QoR-15) Score at Postoperative 24 Hours
Časové okno: Postoperative 24 hours
|
Quality of Recovery-15 (QoR-15) Total Score at Postoperative 24 Hours Postoperative recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. The QoR-15 is a validated patient-reported outcome measure consisting of 15 items that evaluate pain, physical comfort, emotional state, physical independence, and psychological support. Total scores range from 0 to 150, with higher scores indicating better postoperative recovery and a higher quality of recovery. |
Postoperative 24 hours
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score
Časové okno: PACU, 2, 6, 12, and 24 hours postoperatively
|
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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PACU, 2, 6, 12, and 24 hours postoperatively
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Postoperative Shoulder Pain Score
Časové okno: 24 hours postoperatively
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The severity of postoperative shoulder pain associated with laparoscopic surgery will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater shoulder pain severity.
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24 hours postoperatively
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Total Opioid Consumption During the First 24 Postoperative Hours
Časové okno: 24 hours postoperatively
|
The cumulative amount of opioid analgesics administered during the first 24 postoperative hours will be recorded. Unit of Measure: microgram fentanyl |
24 hours postoperatively
|
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Time to First Rescue Analgesic Requirement
Časové okno: 24 hours postoperatively
|
The time elapsed between the end of surgery and the first administration of rescue analgesic medication will be recorded. Unit of Measure: minutes |
24 hours postoperatively
|
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Incidence of Postoperative Nausea and Vomiting (PONV)
Časové okno: 24 hours postoperatively
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The occurrence of postoperative nausea and/or vomiting during the first 24 postoperative hours will be recorded. Unit of Measure: participants with PONV (%) |
24 hours postoperatively
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Leyla SIVACIGIL, MD, Taksim Training and Research Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Pooperační komplikace
- Patologické procesy
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolest, pooperační
- Organické chemikálie
- Ethers
- Uhlovodíky
- Anilides
- Amidy
- Anilinové sloučeniny
- Aminy
- Uhlovodíky, halogenované
- Uhlovodíky, fluorované
- MethylEthers
- Sevofluran
- Bupivakain
Další identifikační čísla studie
- E-48670771-514.99-311790631
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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