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

NCT07653490 | Not Yet Recruiting

• 1 other identifier: E-48670771-514.99-311790631
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Laparoscopic Cholecystectomy

Keywords

Erector Spinae Plane Block; Low-Flow Anaesthesia; Opioid Consumption; Enhanced Recovery; Laparoscopic Cholecystectomy

Outcome Measures

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.

  Postoperative 24 hours

Secondary Outcomes (5)

• Numeric Rating Scale (NRS) Pain Score

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

• Postoperative Shoulder Pain Score

  24 hours postoperatively

• Total Opioid Consumption During the First 24 Postoperative Hours

  24 hours postoperatively

• Time to First Rescue Analgesic Requirement

  24 hours postoperatively

• Incidence of Postoperative Nausea and Vomiting (PONV)

  24 hours postoperatively

Study Arms (2)

ESPB + Standard-Flow Anaesthesia

ACTIVE COMPARATOR

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.

Procedure: Erector Spinae Plane Block; Other: Standard Fresh Gas Flow (3 L/min); Drug: Bupivacaine; Drug: Sevoflurane

ESPB + Low-Flow Anaesthesia

EXPERIMENTAL

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.

Procedure: Erector Spinae Plane Block; Other: Low Fresh Gas Flow (0.5 L/min); Drug: Bupivacaine; Drug: Sevoflurane

Interventions

Erector Spinae Plane Block PROCEDURE

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

ESPB + Low-Flow Anaesthesia; ESPB + Standard-Flow Anaesthesia

Low Fresh Gas Flow (0.5 L/min) OTHER

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.

ESPB + Low-Flow Anaesthesia

Standard Fresh Gas Flow (3 L/min) OTHER

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.

ESPB + Standard-Flow 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.

ESPB + Low-Flow Anaesthesia; ESPB + Standard-Flow Anaesthesia

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.

ESPB + Low-Flow Anaesthesia; ESPB + Standard-Flow Anaesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taksim Egitim ve Arastirma Hastanesi: lead

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sevoflurane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Leyla SIVACIGIL, MD

  Taksim Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyla Sivacigil, MD

CONTACT

90 5065983478; veralleyla@hotmail.com

Celal Kaya, MD

CONTACT

90 5435176760; celalmadime@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to two parallel groups: an erector spinae plane block (ESPB) plus low-flow anaesthesia group and an ESPB plus standard-flow anaesthesia group. Postoperative quality of recovery, pain scores, and opioid consumption will be compared between the groups in patients undergoing elective laparoscopic cholecystectomy.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): May 22, 2027
• Study Completion (Estimated): June 22, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share