CholelithiasisESP-LCNCT07478601
Effect of Erector Spinae Plane Block on Postoperative Respiratory Function After Laparoscopic Cholecystectomy
A study testing Erector Spinae Plane Block in people with Cholelithiasis, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pulmonary dysfunction is frequently observed after laparoscopic abdominal surgery due to the combined effects of general anesthesia, pneumoperitoneum, diaphragmatic dysfunction, and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2026to 25 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years ASA physical status I-III-- III Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia Ability to perform spirometry tests Provision of written informed consent
Who cannot join
- Patient refusal to participate Chronic pulmonary disease (e.g., COPD, asthma, restrictive lung disease) Morbid obesity (BMI ≥ 35 kg/m²) Coagulopathy or anticoagulant therapy Local infection at the block site Allergy to local anesthetic agents Pregnancy Previous thoracic surgery Neuromuscular disease affecting respiratory function Conversion from laparoscopic to open surgery Inability to perform postoperative spirometry
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
Bursa Uludağ University Faculty of Medicine Hospital
Bursa, Bursa, 16059
Selcan Akesen, Associate Professor, MD, 0090224 2950000, selcanakesen@uludag.edu.tr
Selcan Akesen, Associate Professor, MD
About this study
Official title: Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Pain and Respiratory Function in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
Postoperative pulmonary dysfunction is frequently observed after laparoscopic abdominal surgery due to the combined effects of general anesthesia, pneumoperitoneum, diaphragmatic dysfunction, and postoperative pain. These factors may impair respiratory mechanics, reduce lung volumes, and negatively affect postoperative recovery. Effective postoperative analgesia plays a crucial role in preserving respiratory function by allowing adequate ventilation and reducing pain-related respiratory limitation.
The erector spinae plane (ESP) block is a relatively novel ultrasound-guided fascial plane block that provides thoracoabdominal analgesia through the spread of local anesthetic along the paraspinal fascial planes. By reducing postoperative pain and opioid consumption, ESP block may contribute to improved respiratory mechanics and preservation of postoperative pulmonary function.
Read more
The aim of this prospective randomized controlled study is to evaluate the effect of ultrasound-guided erector spinae plane block on postoperative respiratory function and pain in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized into two groups: an ESP block group receiving bilateral ultrasound-guided erector spinae plane block and a control group receiving standard analgesic management.
Postoperative respiratory parameters will be evaluated using spirometry measurements including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75). In addition, arterial blood gas parameters and postoperative pain scores will be assessed and compared between the groups.
The study aims to determine whether ultrasound-guided erector spinae plane block improves postoperative respiratory function and contributes to better postoperative recovery in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Postoperative pulmonary dysfunction is a common complication following laparoscopic abdominal surgery. Several factors contribute to this condition, including the effects of general anesthesia, diaphragmatic dysfunction caused by pneumoperitoneum, decreased functional residual capacity, and postoperative pain that limits effective ventilation and coughing. These mechanisms may lead to reduced lung volumes, impaired respiratory mechanics, and an increased risk of postoperative pulmonary complications.
Adequate postoperative analgesia is a key component of perioperative care because pain following upper abdominal surgery may inhibit deep breathing and reduce chest wall expansion. As a result, insufficient analgesia can further aggravate postoperative respiratory dysfunction. Regional anesthesia techniques have therefore gained increasing interest in multimodal analgesic strategies to improve postoperative outcomes.
The erector spinae plane (ESP) block is a relatively recent ultrasound-guided fascial plane block that involves injection of local anesthetic into the fascial plane deep to the erector spinae muscle. The spread of local anesthetic along the thoracolumbar fascia allows analgesic coverage of multiple thoracic dermatomes and provides effective thoracoabdominal analgesia. Previous studies have demonstrated that ESP block can reduce postoperative pain scores and opioid consumption in various abdominal and thoracic surgical procedures.
Improved postoperative analgesia may also contribute to better preservation of respiratory mechanics. By reducing pain during breathing and coughing, ESP block may facilitate deeper inspiration, improve lung expansion, and support the maintenance of postoperative pulmonary function. However, the effect of ESP block on objective respiratory function parameters following laparoscopic cholecystectomy has not been fully clarified.
This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided erector spinae plane block on postoperative respiratory function and pain in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomly assigned to either an ESP block group or a control group receiving standard analgesic management.
Postoperative respiratory function will be assessed using spirometry measurements, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow between 25% and 75% of the pulmonary volume (FEF25-75). Arterial blood gas parameters will also be evaluated. Pain intensity will be assessed using the visual analog scale (VAS), and postoperative analgesic consumption will be recorded.
The primary objective of this study is to determine whether ultrasound-guided erector spinae plane block preserves postoperative respiratory function after laparoscopic cholecystectomy. Secondary objectives include evaluation of postoperative pain scores, analgesic requirements, and arterial blood gas parameters.
- Conditions
- Cholelithiasis
- Being tested
- Erector Spinae Plane Block
- Keywords
- Cholelithiasis, Erector Spinae Plane Block, Postoperative Respiratory Function, Laparoscopic Cholecystectomy, Postoperative Pain, Regional Anesthesia, Spirometry
- Medical subject headings
- Cholelithiasis, 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
Ultrasound-guided bilateral erector spinae plane block performed at the thoracic level following induction of general anesthesia to provide postoperative thoracoabdominal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block Group | Experimental | Patients undergoing elective laparoscopic cholecystectomy who will receive bilateral ultrasound-guided erector spinae plane block in addition to standard general anesthesia for postoperative analgesia. Receives: Procedure: Erector Spinae Plane Block |
| Control Group | No intervention | Patients undergoing elective laparoscopic cholecystectomy who will receive standard general anesthesia and postoperative analgesic management without erector spinae plane block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in 1 Second (FEV1)
Postoperative respiratory function will be assessed by spirometry measurement of forced expiratory volume in 1 second (FEV1). Changes in FEV1 from baseline will be compared between the ultrasound-guided erector spinae plane block group and the control group in patients undergoing elective laparoscopic cholecystectomy.
Measured: Preoperative, postoperative 6 hours, and postoperative 24 hours
Change in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) will be measured by spirometry to evaluate postoperative respiratory function. Changes in FVC from baseline will be compared between the erector spinae plane block group and the control group.
Measured: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Secondary outcomes (5)
Change in FEV1/FVC Ratio
The FEV1/FVC ratio will be assessed using spirometry to evaluate postoperative ventilatory function and will be compared between study groups.
Measured: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Change in Forced Expiratory Flow 25-75% (FEF25-75)
Forced expiratory flow between 25% and 75% of forced vital capacity (FEF25-75) will be measured by spirometry to evaluate small airway function and compared between the erector spinae plane block group and the control group.
Measured: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Change in Arterial Blood Gas Parameters
Arterial blood gas analysis will be performed to evaluate perioperative respiratory status. Parameters including pH, PaO2, and PaCO2 will be compared between groups.
Measured: Preoperative baseline and postoperative 6 hours
Postoperative Pain Intensity (VAS)
Postoperative pain intensity will be assessed using the visual analog scale (VAS). Pain scores will be compared between the erector spinae plane block group and the control group.
Measured: Postoperative 1 hour, 6 hours, and 24 hours
Postoperative Analgesic Consumption
Total postoperative analgesic consumption will be recorded and compared between study groups.
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start24 May 2026 (estimated)
- Primary completion24 May 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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. The intervention group will receive bilateral ultrasound-guided erector spinae plane block in addition to standard general anesthesia, while the control group will receive standard general anesthesia and postoperative analgesia without erector spinae plane block.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcan Akesen, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478601
- Sponsor's protocol ID
- ESP-LC-2026
- Acronym
- ESP-LC
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to institutional data protection policies and ethical considerations regarding patient confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Pain and Respiratory Function in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07478601
- Acronym / sponsor ID
- ESP-LC / ESP-LC-2026
- Conditions
- Cholelithiasis
- Keywords
- Cholelithiasis, Erector Spinae Plane Block, Postoperative Respiratory Function, Laparoscopic Cholecystectomy, Postoperative Pain, Regional Anesthesia, Spirometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 24 May 2026 (estimated)
- Primary completion
- 24 May 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 17 Mar 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.
Postoperative pulmonary dysfunction is frequently observed after laparoscopic abdominal surgery due to the combined effects of general anesthesia, pneumoperitoneum, diaphragmatic dysfunction, and postoperative pain. These factors may impair respiratory mechanics, reduce lung volumes, and negatively affect postoperative recovery. Effective postoperative analgesia plays a crucial role in preserving respiratory function by allowing adequate ventilation and reducing pain-related respiratory limitation.
The erector spinae plane (ESP) block is a relatively novel ultrasound-guided fascial plane block that provides thoracoabdominal analgesia through the spread of local anesthetic along the paraspinal fascial planes. By reducing postoperative pain and opioid consumption, ESP block may contribute to improved respiratory mechanics and preservation of postoperative pulmonary function.
The aim of this prospective randomized controlled study is to evaluate the effect of ultrasound-guided erector spinae plane block on postoperative respiratory function and pain in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized into two groups: an ESP block group receiving bilateral ultrasound-guided erector spinae plane block and a control group receiving standard analgesic management.
Postoperative respiratory parameters will be evaluated using spirometry measurements including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75). In addition, arterial blood gas parameters and postoperative pain scores will be assessed and compared between the groups.
The study aims to determine whether ultrasound-guided erector spinae plane block improves postoperative respiratory function and contributes to better postoperative recovery in patients undergoing laparoscopic cholecystectomy.
Detailed description
Postoperative pulmonary dysfunction is a common complication following laparoscopic abdominal surgery. Several factors contribute to this condition, including the effects of general anesthesia, diaphragmatic dysfunction caused by pneumoperitoneum, decreased functional residual capacity, and postoperative pain that limits effective ventilation and coughing. These mechanisms may lead to reduced lung volumes, impaired respiratory mechanics, and an increased risk of postoperative pulmonary complications.
Adequate postoperative analgesia is a key component of perioperative care because pain following upper abdominal surgery may inhibit deep breathing and reduce chest wall expansion. As a result, insufficient analgesia can further aggravate postoperative respiratory dysfunction. Regional anesthesia techniques have therefore gained increasing interest in multimodal analgesic strategies to improve postoperative outcomes.
The erector spinae plane (ESP) block is a relatively recent ultrasound-guided fascial plane block that involves injection of local anesthetic into the fascial plane deep to the erector spinae muscle. The spread of local anesthetic along the thoracolumbar fascia allows analgesic coverage of multiple thoracic dermatomes and provides effective thoracoabdominal analgesia. Previous studies have demonstrated that ESP block can reduce postoperative pain scores and opioid consumption in various abdominal and thoracic surgical procedures.
Improved postoperative analgesia may also contribute to better preservation of respiratory mechanics. By reducing pain during breathing and coughing, ESP block may facilitate deeper inspiration, improve lung expansion, and support the maintenance of postoperative pulmonary function. However, the effect of ESP block on objective respiratory function parameters following laparoscopic cholecystectomy has not been fully clarified.
This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided erector spinae plane block on postoperative respiratory function and pain in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomly assigned to either an ESP block group or a control group receiving standard analgesic management.
Postoperative respiratory function will be assessed using spirometry measurements, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow between 25% and 75% of the pulmonary volume (FEF25-75). Arterial blood gas parameters will also be evaluated. Pain intensity will be assessed using the visual analog scale (VAS), and postoperative analgesic consumption will be recorded.
The primary objective of this study is to determine whether ultrasound-guided erector spinae plane block preserves postoperative respiratory function after laparoscopic cholecystectomy. Secondary objectives include evaluation of postoperative pain scores, analgesic requirements, and arterial blood gas parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two parallel groups. The intervention group will receive bilateral ultrasound-guided erector spinae plane block in addition to standard general anesthesia, while the control group will receive standard general anesthesia and postoperative analgesia without erector spinae plane block.
| Arm | Type | Receives |
|---|---|---|
| ESP Block Group | Experimental | Procedure: Erector Spinae Plane BlockPatients undergoing elective laparoscopic cholecystectomy who will receive bilateral ultrasound-guided erector spinae plane block in addition to standard general anesthesia for postoperative analgesia. |
| Control Group | No intervention | –Patients undergoing elective laparoscopic cholecystectomy who will receive standard general anesthesia and postoperative analgesic management without erector spinae plane block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 and 65 years ASA physical status I-III-- III Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia Ability to perform spirometry tests Provision of written informed consent
Key exclusion criteria (1 listed)
- Patient refusal to participate Chronic pulmonary disease (e.g., COPD, asthma, restrictive lung disease) Morbid obesity (BMI ≥ 35 kg/m²) Coagulopathy or anticoagulant therapy Local infection at the block site Allergy to local anesthetic agents Pregnancy Previous thoracic surgery Neuromuscular disease affecting respiratory function Conversion from laparoscopic to open surgery Inability to perform postoperative spirometry
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 BlockUltrasound-guided bilateral erector spinae plane block performed at the thoracic level following induction of general anesthesia to provide postoperative thoracoabdominal analgesia. | Procedure or surgery | ESP Block Group |
Primary outcome
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Preoperative, postoperative 6 hours, and postoperative 24 hours
Postoperative respiratory function will be assessed by spirometry measurement of forced expiratory volume in 1 second (FEV1). Changes in FEV1 from baseline will be compared between the ultrasound-guided erector spinae plane block group and the control group in patients undergoing elective laparoscopic cholecystectomy.
Change in Forced Vital Capacity (FVC)
Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Forced vital capacity (FVC) will be measured by spirometry to evaluate postoperative respiratory function. Changes in FVC from baseline will be compared between the erector spinae plane block group and the control group.
5 secondary outcomes
Change in FEV1/FVC Ratio
Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Change in Forced Expiratory Flow 25-75% (FEF25-75)
Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Change in Arterial Blood Gas Parameters
Time frame: Preoperative baseline and postoperative 6 hours
Postoperative Pain Intensity (VAS)
Time frame: Postoperative 1 hour, 6 hours, and 24 hours
Postoperative Analgesic Consumption
Time frame: Within the first 24 hours after surgery
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 17 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to institutional data protection policies and ethical considerations regarding patient confidentiality
Related trials for Cholelithiasis
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
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.
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 in people with Cholelithiasis, run by Uludag University 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Mar 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 Selcan Akesen, Assoc. Prof. MD (00902242953274, selcanakesen@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Preoperative, postoperative 6 hours, and postoperative 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.