Bariatric Sleeve GastrectomyNCT07431905
Effect of Erector Spinae Plane Block on Postoperative Analgesia and Stress Response in Laparoscopic Sleeve Gastrectomy
A study testing Erector Spinae Plane Block in people with Bariatric Sleeve Gastrectomy and Erector Spina Plan Block, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Effective postoperative analgesia is an important component of enhanced recovery after bariatric surgery. The erector spinae plane block (ESPB) is a regional anesthesia technique that has been increasingly used in abdominal and thoracic surgeries; however, its effects on postoperative analgesic requirements, pain… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Sleeve Gastrectomy, Erector Spina Plan Block, Cortisol
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2023to 17 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Body mass index (BMI) > 30 kg/m²
- ASA physical status II-III
- Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
- Ability to provide written and verbal informed consent
Who cannot join
- Age < 18 years or > 65 years
- ASA physical status I, IV, or V
- Body mass index (BMI) < 30 kg/m²
- Contraindications to erector spinae plane block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
- Renal or hepatic insufficiency
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Erector Spinae Plane Block on Postoperative Analgesia and Perioperative Stress Response in Sleeve Gastrectomy: A Prospective Randomized Clinical Trial
Effective postoperative analgesia is an important component of enhanced recovery after bariatric surgery. The erector spinae plane block (ESPB) is a regional anesthesia technique that has been increasingly used in abdominal and thoracic surgeries; however, its effects on postoperative analgesic requirements, pain scores, patient and surgeon satisfaction, hemodynamic parameters, and perioperative stress response in obese patients undergoing sleeve gastrectomy require further evaluation.
This study is designed as a prospective, randomized, single-blind clinical trial. After obtaining ethics committee approval (Şanlıurfa Harran University Hospital, date: 23.01.2023; decision no: HRÜ/23.02.09) and written/verbal informed consent, 60 patients aged 18-65 years, with a body mass index (BMI) >30 and classified as ASA II-III, scheduled for elective sleeve gastrectomy will be included. Patients will be randomized into two groups: a group receiving bilateral ESPB (Group E, n=30) and a control group without ESPB (Group C, n=30).
Read more
Demographic characteristics, ASA classification, comorbidities, and duration of surgery will be recorded. Preoperative venous blood samples will be collected for hemogram (white blood cell count, lymphocyte count, neutrophil count) and biochemical analyses (C-reactive protein, cortisol, and glucose). Standard intraoperative monitoring (electrocardiography, peripheral oxygen saturation, and noninvasive blood pressure) will be applied, and heart rate (HR) and mean arterial pressure (MAP) will be recorded intraoperatively.
Postoperatively, HR and MAP, Numerical Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 24 hours, opioid consumption, patient and surgeon satisfaction scores (Likert scale), postoperative hemogram and biochemical parameters, and any side effects or complications will be documented. All patients will receive dexketoprofen as baseline analgesia, and tramadol hydrochloride will be administered as rescue analgesic when required.
The primary objective of the study is to compare postoperative pain scores and analgesic requirements between patients receiving bilateral ESPB and those not receiving ESPB. Secondary objectives include the assessment of hemodynamic parameters, patient and surgeon satisfaction, and perioperative hematologic, biochemical, and stress-related parameters.
- Conditions
- Bariatric Sleeve Gastrectomy, Erector Spina Plan Block, Cortisol, Numerical Rating Scale, Opioid Analgesia
- Being tested
- Erector Spinae Plane Block, Control
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
Patients in the intervention group received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) in addition to standardized general anesthesia and multimodal analgesia. The block was performed 30 minutes before surgery in the preoperative area by an experienced anesthesiologist under aseptic conditions. With the patient in the prone position, a linear ultrasound probe was placed at the T7-T8 vertebral level to identify the transverse process and erector spinae muscle. Using an in-plane technique, a 22-gauge, 100-mm needle was advanced to the transverse process, and 20 mL of a local anesthetic mixture (lidocaine 2%, bupivacaine 0.25%, and saline) was injected into the fascial plane deep to the erector spinae muscle on each side. Dermatomal sensory assessment was performed before transfer to the operating room. All patients subsequently underwent identical general anesthesia protocols. The control group did not receive any regional block and was managed with the
ControlProcedure or surgery
Patients allocated to the control group received standardized general anesthesia and postoperative multimodal analgesia without any regional anesthesia technique. No erector spinae plane block or other peripheral nerve block was performed. General anesthesia induction and maintenance protocols were identical to those used in the intervention group, ensuring comparable intraoperative management. At the end of surgery, all patients received intravenous tramadol as part of the standardized analgesic regimen. Postoperatively, scheduled non-opioid analgesia was administered to all patients. Intravenous tramadol was provided as rescue analgesia when Numerical Rating Scale (NRS) pain scores were ≥4 or upon patient request. Perioperative monitoring, postoperative assessments, and data collection procedures were identical between groups.
| Study group | Role | What they receive |
|---|---|---|
| Group ESPB | Active comparator | Not described Receives: Procedure: Erector Spinae Plane Block |
| Group Control | Placebo comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
Measured: 24 hours after surgery
Secondary outcomes (15)
Body Weight (kilograms)
Body weight measured in kilograms (kg) using a calibrated hospital scale. Higher values indicate greater body weight.
Measured: At baseline (preoperatively)
Height (centimeters)
Height measured in centimeters (cm) using a standard stadiometer. Higher values indicate greater height.
Measured: At baseline (preoperatively)
Body Mass Index (BMI, kg/m²)
Calculated as weight (kg) divided by height squared (m²).
Measured: At baseline (preoperatively)
Postoperative Rescue Opioid Consumption (Intravenous Tramadol, mg)
Measured: During the first 24 hours postoperatively
Perioperative Heart Rate (beats per minute)
Measured: Intraoperatively and during the first 24 hours postoperatively
Mean Arterial Pressure (mmHg)
Measured: Intraoperatively and during the first 24 hours postoperatively
Patient Satisfaction Assessed by a 5-Point Likert Scale at 24 Hours
5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction.
Measured: 24 hours postoperatively
Serum Cortisol Level (mg/dL)
Measured: From preoperative baseline to 24 hours postoperatively
Serum C-Reactive Protein (CRP) Level (mg/L)
Measured: From preoperative baseline to 24 hours postoperatively
Blood Glucose Level (mg/dL)
Measured: From preoperative baseline to 24 hours postoperatively
White Blood Cell Count (×10³/mm³)
Measured: From preoperative baseline to 24 hours postoperatively
Lymphocyte Percentage (%)
Measured: From preoperative baseline to 24 hours postoperatively
Absolute Lymphocyte Count (×10³/mm³)
Measured: From preoperative baseline to 24 hours postoperatively
Neutrophil Percentage (%)
Measured: From preoperative baseline to 24 hours postoperatively
Absolute Neutrophil Count (×10³/mm³)
Measured: From preoperative baseline to 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 posted25 Feb 2026
- Study start5 Feb 2023
- Primary completion10 Feb 2024
- Study completion17 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Sleeve GastrectomyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kutay Baris FILAZI, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431905
- Sponsor's protocol ID
- HRÜ/23.02.09
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Erector Spinae Plane Block on Postoperative Analgesia and Perioperative Stress Response in Sleeve Gastrectomy: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07431905
- Acronym / sponsor ID
- HRÜ/23.02.09
- Conditions
- Bariatric Sleeve Gastrectomy, Erector Spina Plan Block, Cortisol, Numerical Rating Scale, Opioid Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 25 Feb 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.
Effective postoperative analgesia is an important component of enhanced recovery after bariatric surgery. The erector spinae plane block (ESPB) is a regional anesthesia technique that has been increasingly used in abdominal and thoracic surgeries; however, its effects on postoperative analgesic requirements, pain scores, patient and surgeon satisfaction, hemodynamic parameters, and perioperative stress response in obese patients undergoing sleeve gastrectomy require further evaluation.
This study is designed as a prospective, randomized, single-blind clinical trial. After obtaining ethics committee approval (Şanlıurfa Harran University Hospital, date: 23.01.2023; decision no: HRÜ/23.02.09) and written/verbal informed consent, 60 patients aged 18-65 years, with a body mass index (BMI) >30 and classified as ASA II-III, scheduled for elective sleeve gastrectomy will be included. Patients will be randomized into two groups: a group receiving bilateral ESPB (Group E, n=30) and a control group without ESPB (Group C, n=30).
Demographic characteristics, ASA classification, comorbidities, and duration of surgery will be recorded. Preoperative venous blood samples will be collected for hemogram (white blood cell count, lymphocyte count, neutrophil count) and biochemical analyses (C-reactive protein, cortisol, and glucose). Standard intraoperative monitoring (electrocardiography, peripheral oxygen saturation, and noninvasive blood pressure) will be applied, and heart rate (HR) and mean arterial pressure (MAP) will be recorded intraoperatively.
Postoperatively, HR and MAP, Numerical Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 24 hours, opioid consumption, patient and surgeon satisfaction scores (Likert scale), postoperative hemogram and biochemical parameters, and any side effects or complications will be documented. All patients will receive dexketoprofen as baseline analgesia, and tramadol hydrochloride will be administered as rescue analgesic when required.
The primary objective of the study is to compare postoperative pain scores and analgesic requirements between patients receiving bilateral ESPB and those not receiving ESPB. Secondary objectives include the assessment of hemodynamic parameters, patient and surgeon satisfaction, and perioperative hematologic, biochemical, and stress-related parameters.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ESPB | Active comparator | Procedure: Erector Spinae Plane Block |
| Group Control | Placebo comparator | Procedure: Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Body mass index (BMI) > 30 kg/m²
- ASA physical status II-III
- Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
- Ability to provide written and verbal informed consent
Key exclusion criteria (6 listed)
- Age < 18 years or > 65 years
- ASA physical status I, IV, or V
- Body mass index (BMI) < 30 kg/m²
- Contraindications to erector spinae plane block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
- Renal or hepatic insufficiency
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 BlockPatients in the intervention group received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) in addition to standardized general anesthesia and multimodal analgesia. The block was performed 30 minutes before surgery in the preoperative area by an experienced anesthesiologist under aseptic conditions. With the patient in the prone position, a linear ultrasound probe was placed at the T7-T8 vertebral level to identify the transverse process and erector spinae muscle. Using an in-plane technique, a 22-gauge, 100-mm needle was advanced to the transverse process, and 20 mL of a local anesthetic mixture (lidocaine 2%, bupivacaine 0.25%, and saline) was injected into the fascial plane deep to the erector spinae muscle on each side. Dermatomal sensory assessment was performed before transfer to the operating room. All patients subsequently underwent identical general anesthesia protocols. The control group did not receive any regional block and was managed with the | Procedure or surgery | Group ESPB |
| ControlPatients allocated to the control group received standardized general anesthesia and postoperative multimodal analgesia without any regional anesthesia technique. No erector spinae plane block or other peripheral nerve block was performed. General anesthesia induction and maintenance protocols were identical to those used in the intervention group, ensuring comparable intraoperative management. At the end of surgery, all patients received intravenous tramadol as part of the standardized analgesic regimen. Postoperatively, scheduled non-opioid analgesia was administered to all patients. Intravenous tramadol was provided as rescue analgesia when Numerical Rating Scale (NRS) pain scores were ≥4 or upon patient request. Perioperative monitoring, postoperative assessments, and data collection procedures were identical between groups. | Procedure or surgery | Group Control |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: 24 hours after surgery
The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
15 secondary outcomes
Body Weight (kilograms)
Time frame: At baseline (preoperatively)
Height (centimeters)
Time frame: At baseline (preoperatively)
Body Mass Index (BMI, kg/m²)
Time frame: At baseline (preoperatively)
Postoperative Rescue Opioid Consumption (Intravenous Tramadol, mg)
Time frame: During the first 24 hours postoperatively
Perioperative Heart Rate (beats per minute)
Time frame: Intraoperatively and during the first 24 hours postoperatively
Mean Arterial Pressure (mmHg)
Time frame: Intraoperatively and during the first 24 hours postoperatively
Patient Satisfaction Assessed by a 5-Point Likert Scale at 24 Hours
Time frame: 24 hours postoperatively
Serum Cortisol Level (mg/dL)
Time frame: From preoperative baseline to 24 hours postoperatively
Serum C-Reactive Protein (CRP) Level (mg/L)
Time frame: From preoperative baseline to 24 hours postoperatively
Blood Glucose Level (mg/dL)
Time frame: From preoperative baseline to 24 hours postoperatively
White Blood Cell Count (×10³/mm³)
Time frame: From preoperative baseline to 24 hours postoperatively
Lymphocyte Percentage (%)
Time frame: From preoperative baseline to 24 hours postoperatively
Absolute Lymphocyte Count (×10³/mm³)
Time frame: From preoperative baseline to 24 hours postoperatively
Neutrophil Percentage (%)
Time frame: From preoperative baseline to 24 hours postoperatively
Absolute Neutrophil Count (×10³/mm³)
Time frame: From preoperative baseline to 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Bariatric Sleeve Gastrectomy and Erector Spina Plan Block, run by Harran 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 25 Feb 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: 24 hours after surgery). 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 25 Feb 2026.