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).
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
- Conditions the study is for
- Postoperative Pain, Laparoscopic Cholecystectomy
- 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Taksim Training and Research Hospital
Istanbul, 34000
Leyla Sivacigil, MD, 905065983478, veralleyla@hotmail.com
Celal Kaya, MD, 905435176760, celalmadime@gmail.com
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.
- Conditions
- Postoperative Pain, 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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
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
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
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
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.
- First posted17 Jun 2026
- Study start18 Jun 2026
- Primary completion18 May 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Leyla SIVACIGIL, MD, Principal investigator, Taksim Training and Research Hospital
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 27413741Kutlusoy 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 36412300Saleem 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 40240902Stark 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07653490
- Acronym / sponsor ID
- E-48670771-514.99-311790631
- Conditions
- Postoperative Pain, Laparoscopic Cholecystectomy
- Keywords
- Erector Spinae Plane Block, Low-Flow Anaesthesia, Opioid Consumption, Enhanced Recovery, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ESPB + Standard-Flow Anaesthesia | Active comparator | Procedure: Erector Spinae Plane Block, Other: Standard Fresh Gas Flow (3 L/min), Drug: Bupivacaine, Drug: SevofluraneParticipants 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. |
| ESPB + Low-Flow Anaesthesia | Experimental | Procedure: Erector Spinae Plane Block, Other: Low Fresh Gas Flow (0.5 L/min), Drug: Bupivacaine, Drug: SevofluraneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Coagulopathy or bleeding disorders
- Allergy to local anaesthetic agents
- Infection at the block application site
- Neurological or psychiatric disorders
- Communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockBilateral ultrasound-guided erector spinae plane block (ESPB) will be performed preoperatively at the T7-T8 level | Procedure or surgery | ESPB + Low-Flow Anaesthesia, ESPB + Standard-Flow Anaesthesia |
| Low Fresh Gas Flow (0.5 L/min)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. | Other | ESPB + Low-Flow Anaesthesia |
| Standard Fresh Gas Flow (3 L/min)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. | Other | ESPB + Standard-Flow Anaesthesia |
| BupivacaineBupivacaine 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. | Drug | ESPB + Low-Flow Anaesthesia, ESPB + Standard-Flow Anaesthesia |
| SevofluraneSevoflurane 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. | Drug | ESPB + Low-Flow Anaesthesia, ESPB + Standard-Flow Anaesthesia |
Primary outcome
Quality of Recovery-15 (QoR-15) Score at Postoperative 24 Hours
Time frame: 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.
5 secondary outcomes
Numeric Rating Scale (NRS) Pain Score
Time frame: PACU, 2, 6, 12, and 24 hours postoperatively
Postoperative Shoulder Pain Score
Time frame: 24 hours postoperatively
Total Opioid Consumption During the First 24 Postoperative Hours
Time frame: 24 hours postoperatively
Time to First Rescue Analgesic Requirement
Time frame: 24 hours postoperatively
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: PubMed 27413741Doger 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.
- Results publication: PubMed 36412300Kutlusoy 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.
- Results publication: PubMed 40240902Saleem 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.
- Results publication: PubMed 23411725Stark 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly in order to protect participant confidentiality and institutional data privacy policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leyla SIVACIGIL, MD principal investigator
Taksim Training and Research Hospital
1 site in 1 country: see every site and its status.
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.