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Postoperative PainNCT07653490

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

A study testing Erector Spinae Plane Block, Low Fresh Gas Flow (0.5 L/min) and Standard Fresh Gas Flow (3 L/min) in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Erector Spinae Plane Block, Low Fresh Gas Flow (0.5 L/min) and Standard Fresh Gas Flow (3 L/min)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jun 2026to 18 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leyla Sivacigil, MD contact

90 5065983478

veralleyla@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Taksim Training and Research Hospital

    Istanbul, 34000

    Leyla Sivacigil, MD, 905065983478, veralleyla@hotmail.com

    Celal Kaya, MD, 905435176760, celalmadime@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Erector Spinae Plane Block, Low Fresh Gas Flow (0.5 L/min), Standard Fresh Gas Flow (3 L/min), Bupivacaine, Sevoflurane
Keywords
Erector Spinae Plane Block, Low-Flow Anaesthesia, Opioid Consumption, Enhanced Recovery, Laparoscopic Cholecystectomy
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane BlockProcedure or 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

    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

    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.

  • BupivacaineDrug

    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.

  • SevofluraneDrug

    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.

Study groups in NCT07653490
Study groupRoleWhat they receive
ESPB + Standard-Flow AnaesthesiaActive comparatorParticipants 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.
Receives: Procedure: Erector Spinae Plane Block; Other: Standard Fresh Gas Flow (3 L/min); Drug: Bupivacaine; Drug: Sevoflurane
ESPB + Low-Flow AnaesthesiaExperimentalParticipants 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.
Receives: Procedure: Erector Spinae Plane Block; Other: Low Fresh Gas Flow (0.5 L/min); Drug: Bupivacaine; Drug: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Postoperative 24 hours

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 24 hours postoperatively

  5. Incidence of Postoperative Nausea and Vomiting (PONV)

    The occurrence of postoperative nausea and/or vomiting during the first 24 postoperative hours will be recorded.

    Unit of Measure: participants with PONV (%)

    Measured: 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start18 Jun 2026
  3. Primary completion18 May 2027 (estimated)
  4. Study completion18 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07653490
Sponsor's protocol ID
E-48670771-514.99-311790631
Status last verified
Jun 2026
First submitted
4 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly in order to protect participant confidentiality and institutional data privacy policies.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23411725

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block, Low Fresh Gas Flow (0.5 L/min) and Standard Fresh Gas Flow (3 L/min) in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leyla Sivacigil, MD (90 5065983478, veralleyla@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-15 (QoR-15) Score at Postoperative 24 Hours (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07653490, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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