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

ConditionsPostoperative PainLaparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTaksim Egitim ve Arastirma Hastanesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-65 years

ASA physical status I-II

Body mass index (BMI) <35 kg/m²

Scheduled for elective laparoscopic cholecystectomy

Disqualifiers

Coagulopathy or bleeding disorders

Allergy to local anaesthetic agents

Infection at the block application site

Neurological or psychiatric disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector Spinae Plane Block

    Procedure/Surgery

    Bilateral ultrasound-guided erector spinae plane block (ESPB) will be performed preoperatively at the T7-T8 level

  • Low Fresh Gas Flow (0.5 L/min)

    Other intervention

    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.

  • Standard Fresh Gas Flow (3 L/min)

    Other intervention

    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

    Drug

    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

    Drug

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: ESPB + Standard-Flow AnaesthesiaActive comparator 4 interventions
Group B: ESPB + Low-Flow AnaesthesiaExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Quality of Recovery-15 (QoR-15) Score at 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.

Time frame
Postoperative 24 hours

Secondary outcomes

1

Numeric Rating Scale (NRS) Pain Score

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.

Time frame
PACU, 2, 6, 12, and 24 hours postoperatively
2

Postoperative Shoulder Pain Score

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.

Time frame
24 hours postoperatively
3

Total Opioid Consumption During the First 24 Postoperative Hours

The cumulative amount of opioid analgesics administered during the first 24 postoperative hours will be recorded. Unit of Measure: microgram fentanyl

Time frame
24 hours postoperatively
4

Time to First Rescue Analgesic Requirement

The time elapsed between the end of surgery and the first administration of rescue analgesic medication will be recorded. Unit of Measure: minutes

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taksim Egitim ve Arastirma Hastanesi

Lead sponsor

Source ClinicalTrials.gov
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