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

18. juni 2026 oppdatert av: Taksim Egitim ve Arastirma Hastanesi

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

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

72

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Istanbul, Tyrkia (Türkiye), 34000
        • Rekruttering
        • Taksim Training and Research Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Leyla Sivacigil, MD
        • Underetterforsker:
          • celal kaya, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Recovery-15 (QoR-15) Score at Postoperative 24 Hours
Tidsramme: 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

Sekundære resultatmål

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

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Leyla SIVACIGIL, MD, Taksim Training and Research Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. juni 2026

Primær fullføring (Antatt)

18. mai 2027

Studiet fullført (Antatt)

18. juni 2027

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared publicly in order to protect participant confidentiality and institutional data privacy policies.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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