Obesity Postoperative PainPGB-ESPNCT07811206
Comparison of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain After Sleeve Gastrectomy
A study testing Paragastric Nerve Block (PGNB), ESPB and Active Comparator in people with Obesity Postoperative Pain and Obesity Morbid Obesity Postoperative Pain, run by Atlas University.
Trial summary
Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed bariatric procedures for the treatment of obesity. Despite its minimally invasive nature, patients frequently experience moderate to severe postoperative pain, which may delay mobilization, prolong hospital stay, increase opioid… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Postoperative Pain, Obesity Morbid Obesity Postoperative Pain
- What is being tested?
- Paragastric Nerve Block (PGNB), ESPB and Active Comparator
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Known allergy or hypersensitivity to local anesthetic agents Allergy or contraindication to paracetamol or NSAIDs Coagulopathy or current anticoagulant therapy Infection or skin lesions at the site of block application Chronic pain syndrome Chronic opioid use, opioid dependence, or use of gabapentin/pregabalin Previous upper gastrointestinal surgery Moderate to severe renal impairment (eGFR <60 mL/min/1.73 m²) Moderate to severe liver disease (Child-Pugh B-C or active hepatic disease) Planned additional surgical procedures Inability to assess pain using VAS Refusal to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Controlled Trial Comparing the Effects of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain Management Following Laparoscopic Sleeve Gastrectomy
Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed bariatric procedures for the treatment of obesity. Despite its minimally invasive nature, patients frequently experience moderate to severe postoperative pain, which may delay mobilization, prolong hospital stay, increase opioid consumption, and reduce patient satisfaction. Effective postoperative pain management is therefore an important component of perioperative care.
Regional analgesia techniques are increasingly used as part of multimodal analgesia protocols to reduce opioid requirements and opioid-related adverse effects. Paragastric nerve block (PGNB) has been reported to provide effective control of visceral pain, nausea, and vomiting after sleeve gastrectomy. Erector spinae plane block (ESPB) is another regional anesthesia technique that has demonstrated efficacy in reducing perioperative opioid consumption in bariatric surgery patients. However, no prospective randomized study has directly compared PGNB and ESPB in patients undergoing sleeve gastrectomy.
This prospective, randomized, controlled clinical trial aims to compare the effects of PGNB, ESPB, and standard analgesia on postoperative pain management following laparoscopic sleeve gastrectomy. Seventy-two adult patients scheduled for elective sleeve gastrectomy will be randomized in a 1:1:1 ratio to receive PGNB, ESPB, or standard multimodal analgesia alone. The primary outcome will be postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, intraoperative remifentanil consumption, additional analgesic requirements, time to first analgesic request, postoperative nausea and vomiting, and block-related complications.
Read the detailed description
Laparoscopic sleeve gastrectomy is one of the most frequently performed bariatric surgical procedures for the treatment of morbid obesity. Although the procedure is minimally invasive, patients commonly experience moderate to severe postoperative pain during the early postoperative period. Inadequate pain control may delay mobilization, prolong hospital stay, increase pulmonary complications, reduce patient satisfaction, and increase opioid consumption, leading to opioid-related adverse effects such as nausea, vomiting, sedation, and respiratory depression.
Regional anesthesia techniques have become an important component of multimodal analgesia protocols aimed at improving postoperative pain control while reducing opioid requirements. Paragastric nerve block (PGNB) is a surgeon-performed regional analgesic technique targeting visceral afferent nerve fibers surrounding the stomach. Previous studies have suggested that PGNB may reduce postoperative pain, opioid consumption, nausea, and vomiting following sleeve gastrectomy. Erector spinae plane block (ESPB) is an ultrasound-guided fascial plane block that has gained popularity in thoracoabdominal surgery because of its ease of application, favorable safety profile, and potential analgesic benefits. ESPB has been shown to reduce perioperative opioid consumption and improve postoperative analgesia in bariatric surgical patients.
Despite the growing use of both techniques, there is limited evidence directly comparing PGNB and ESPB in patients undergoing laparoscopic sleeve gastrectomy. Therefore, the optimal regional analgesic technique for this patient population remains uncertain.
The present study is designed as a prospective, randomized, controlled, parallel-group clinical trial conducted at Atlas University Faculty of Medicine Hospital. Following Institutional Review Board approval and written informed consent, 72 adult patients scheduled for elective laparoscopic sleeve gastrectomy will be enrolled. Eligible participants will be between 18 and 65 years of age, classified as ASA physical status II-III, and meet established bariatric surgery criteria.
Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups:
- Paragastric Nerve Block (PGNB) Group: Patients will receive intraoperative paragastric nerve block performed by the operating surgeon using 18 mL of 0.5% bupivacaine distributed across predefined paragastric anatomical regions.
- Erector Spinae Plane Block (ESPB) Group: Patients will receive bilateral ultrasound-guided ESPB at the T6 vertebral level before surgery using 0.25% bupivacaine, with a maximum dose not exceeding 2 mg/kg.
- Control Group: Patients will receive standard perioperative multimodal analgesia without regional block intervention.
All participants will undergo standardized general anesthesia and multimodal analgesia protocols. Intraoperative remifentanil administration will be titrated according to routine clinical practice.
The primary outcome measure will be postoperative pain intensity assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery.
Secondary outcome measures will include:
- Total postoperative analgesic and opioid consumption during the first 24 hours.
- Additional analgesic requirements.
- Time to first analgesic request.
- Intraoperative remifentanil consumption.
- Incidence of postoperative nausea and vomiting.
- Block-related adverse events and complications, including local anesthetic systemic toxicity, hematoma, or infection.
Postoperative assessments will be performed by investigators blinded to group allocation whenever feasible. Data will be collected during the intraoperative period, post-anesthesia care unit stay, and throughout the first 24 postoperative hours.
The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of PGNB and ESPB for postoperative pain management following laparoscopic sleeve gastrectomy and may contribute to the optimization of perioperative analgesic strategies in bariatric surgery.
- Being tested
- Paragastric Nerve Block (PGNB), ESPB, Active Comparator
- Keywords
- Sleeve Gastrectomy, Bariatric Surgery, Paragastric Nerve Block, Erector Spinae Plane Block,Regional Anesthesia, Postoperative Analgesia, Multimodal Analgesia,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paragastric Nerve Block (PGNB)Procedure or surgery
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
ESPBProcedure or surgery
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine. The total dose will not exceed 2 mg/kg. The block is administered in addition to standard general anesthesia and multimodal analgesia.
Active ComparatorProcedure or surgery
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques. Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Paragastric Nerve Block (PGNB) | Experimental | Participants will receive an intraoperative paragastric nerve block performed by the surgeon using 18 mL of 0.5% bupivacaine administered to predefined paragastric anatomical regions in addition to standard general anesthesia and multimodal analgesia. Receives: Procedure: Paragastric Nerve Block (PGNB); Procedure: ESPB; Procedure: Active Comparator |
| Erector Spinae Plane Block (ESPB) | Experimental | Participants will receive bilateral ultrasound-guided erector spinae plane block at the T6 vertebral level before surgery in addition to standard general anesthesia and multimodal analgesia. Receives: Procedure: Paragastric Nerve Block (PGNB); Procedure: ESPB; Procedure: Active Comparator |
| No Intervention | Active comparator | Participants will receive standard perioperative multimodal analgesia without regional anesthesia. Intravenous paracetamol and dexketoprofen will be administered according to the institutional analgesia protocol. Receives: Procedure: Paragastric Nerve Block (PGNB); Procedure: ESPB; Procedure: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The primary outcome of this study is the assessment of postoperative pain levels. Pain intensity will be measured using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at the 1st, 6th, 12th, and 24th postoperative hours. The effectiveness of the analgesic techniques will be evaluated by comparing VAS scores between the groups.
Measured: Postoperative Hours 1, 6, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity 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
- Eligible patients undergoing elective laparoscopic sleeve gastrectomy will be randomized in a 1:1:1 ratio to one of three parallel groups: Paragastric Nerve Block (PGNB), Erector Spinae Plane Block (ESPB), or standard analgesia (control group). Participants will remain in their assigned treatment group throughout the study, and outcomes will be compared between groups during the first 24 postoperative hours.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ergun Gunduz, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811206
- Sponsor's protocol ID
- ATLAS -PGB-ESP-2026-1
- Acronym
- PGB-ESP
- Status last verified
- Sep 2026
- First submitted
- 23 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains clinical information collected for the primary purpose of this single-center study. Data sharing is not planned due to institutional privacy policies and to protect participant confidentiality. Only aggregated study results will be published.
Publications
Ul Huda A, Alshahrani AS, Yasir M, Sawilah A, Alharthi AAN. Erector spinae block reduces intraoperative and postoperative opioid consumption in patients undergoing laparoscopic sleeve gastrectomy: A randomized controlled trial. Qatar Med J. 2024 Dec 26;2024(4):58. doi: 10.5339/qmj.2024.58. eCollection 2024.
PubMed 39944209Katar MK, Turan UF. Efficacy and Safety of Paragastric Neural Blockade in Controlling Pain, Nausea, and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial. Obes Surg. 2024 Jul;34(7):2383-2390. doi: 10.1007/s11695-024-07255-9. Epub 2024 May 7.
PubMed 38713336
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing the Effects of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain Management Following Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07811206
- Acronym / sponsor ID
- PGB-ESP / ATLAS -PGB-ESP-2026-1
- Keywords
- Sleeve Gastrectomy, Bariatric Surgery, Paragastric Nerve Block, Erector Spinae Plane Block,Regional Anesthesia, Postoperative Analgesia, Multimodal Analgesia,
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 9 Sep 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.
Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed bariatric procedures for the treatment of obesity. Despite its minimally invasive nature, patients frequently experience moderate to severe postoperative pain, which may delay mobilization, prolong hospital stay, increase opioid consumption, and reduce patient satisfaction. Effective postoperative pain management is therefore an important component of perioperative care.
Regional analgesia techniques are increasingly used as part of multimodal analgesia protocols to reduce opioid requirements and opioid-related adverse effects. Paragastric nerve block (PGNB) has been reported to provide effective control of visceral pain, nausea, and vomiting after sleeve gastrectomy. Erector spinae plane block (ESPB) is another regional anesthesia technique that has demonstrated efficacy in reducing perioperative opioid consumption in bariatric surgery patients. However, no prospective randomized study has directly compared PGNB and ESPB in patients undergoing sleeve gastrectomy.
This prospective, randomized, controlled clinical trial aims to compare the effects of PGNB, ESPB, and standard analgesia on postoperative pain management following laparoscopic sleeve gastrectomy. Seventy-two adult patients scheduled for elective sleeve gastrectomy will be randomized in a 1:1:1 ratio to receive PGNB, ESPB, or standard multimodal analgesia alone. The primary outcome will be postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, intraoperative remifentanil consumption, additional analgesic requirements, time to first analgesic request, postoperative nausea and vomiting, and block-related complications.
Detailed description
Laparoscopic sleeve gastrectomy is one of the most frequently performed bariatric surgical procedures for the treatment of morbid obesity. Although the procedure is minimally invasive, patients commonly experience moderate to severe postoperative pain during the early postoperative period. Inadequate pain control may delay mobilization, prolong hospital stay, increase pulmonary complications, reduce patient satisfaction, and increase opioid consumption, leading to opioid-related adverse effects such as nausea, vomiting, sedation, and respiratory depression.
Regional anesthesia techniques have become an important component of multimodal analgesia protocols aimed at improving postoperative pain control while reducing opioid requirements. Paragastric nerve block (PGNB) is a surgeon-performed regional analgesic technique targeting visceral afferent nerve fibers surrounding the stomach. Previous studies have suggested that PGNB may reduce postoperative pain, opioid consumption, nausea, and vomiting following sleeve gastrectomy. Erector spinae plane block (ESPB) is an ultrasound-guided fascial plane block that has gained popularity in thoracoabdominal surgery because of its ease of application, favorable safety profile, and potential analgesic benefits. ESPB has been shown to reduce perioperative opioid consumption and improve postoperative analgesia in bariatric surgical patients.
Despite the growing use of both techniques, there is limited evidence directly comparing PGNB and ESPB in patients undergoing laparoscopic sleeve gastrectomy. Therefore, the optimal regional analgesic technique for this patient population remains uncertain.
The present study is designed as a prospective, randomized, controlled, parallel-group clinical trial conducted at Atlas University Faculty of Medicine Hospital. Following Institutional Review Board approval and written informed consent, 72 adult patients scheduled for elective laparoscopic sleeve gastrectomy will be enrolled. Eligible participants will be between 18 and 65 years of age, classified as ASA physical status II-III, and meet established bariatric surgery criteria.
Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups:
- Paragastric Nerve Block (PGNB) Group: Patients will receive intraoperative paragastric nerve block performed by the operating surgeon using 18 mL of 0.5% bupivacaine distributed across predefined paragastric anatomical regions.
- Erector Spinae Plane Block (ESPB) Group: Patients will receive bilateral ultrasound-guided ESPB at the T6 vertebral level before surgery using 0.25% bupivacaine, with a maximum dose not exceeding 2 mg/kg.
- Control Group: Patients will receive standard perioperative multimodal analgesia without regional block intervention.
All participants will undergo standardized general anesthesia and multimodal analgesia protocols. Intraoperative remifentanil administration will be titrated according to routine clinical practice.
The primary outcome measure will be postoperative pain intensity assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery.
Secondary outcome measures will include:
- Total postoperative analgesic and opioid consumption during the first 24 hours.
- Additional analgesic requirements.
- Time to first analgesic request.
- Intraoperative remifentanil consumption.
- Incidence of postoperative nausea and vomiting.
- Block-related adverse events and complications, including local anesthetic systemic toxicity, hematoma, or infection.
Postoperative assessments will be performed by investigators blinded to group allocation whenever feasible. Data will be collected during the intraoperative period, post-anesthesia care unit stay, and throughout the first 24 postoperative hours.
The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of PGNB and ESPB for postoperative pain management following laparoscopic sleeve gastrectomy and may contribute to the optimization of perioperative analgesic strategies in bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible patients undergoing elective laparoscopic sleeve gastrectomy will be randomized in a 1:1:1 ratio to one of three parallel groups: Paragastric Nerve Block (PGNB), Erector Spinae Plane Block (ESPB), or standard analgesia (control group). Participants will remain in their assigned treatment group throughout the study, and outcomes will be compared between groups during the first 24 postoperative hours.
| Arm | Type | Receives |
|---|---|---|
| Paragastric Nerve Block (PGNB) | Experimental | Procedure: Paragastric Nerve Block (PGNB), Procedure: ESPB, Procedure: Active ComparatorParticipants will receive an intraoperative paragastric nerve block performed by the surgeon using 18 mL of 0.5% bupivacaine administered to predefined paragastric anatomical regions in addition to standard general anesthesia and multimodal analgesia. |
| Erector Spinae Plane Block (ESPB) | Experimental | Procedure: Paragastric Nerve Block (PGNB), Procedure: ESPB, Procedure: Active ComparatorParticipants will receive bilateral ultrasound-guided erector spinae plane block at the T6 vertebral level before surgery in addition to standard general anesthesia and multimodal analgesia. |
| No Intervention | Active comparator | Procedure: Paragastric Nerve Block (PGNB), Procedure: ESPB, Procedure: Active ComparatorParticipants will receive standard perioperative multimodal analgesia without regional anesthesia. Intravenous paracetamol and dexketoprofen will be administered according to the institutional analgesia protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Known allergy or hypersensitivity to local anesthetic agents Allergy or contraindication to paracetamol or NSAIDs Coagulopathy or current anticoagulant therapy Infection or skin lesions at the site of block application Chronic pain syndrome Chronic opioid use, opioid dependence, or use of gabapentin/pregabalin Previous upper gastrointestinal surgery Moderate to severe renal impairment (eGFR <60 mL/min/1.73 m²) Moderate to severe liver disease (Child-Pugh B-C or active hepatic disease) Planned additional surgical procedures Inability to assess pain using VAS Refusal to participate in the study
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 |
|---|---|---|
| Paragastric Nerve Block (PGNB)Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia. | Procedure or surgery | Erector Spinae Plane Block (ESPB), No Intervention, Paragastric Nerve Block (PGNB) |
| ESPBBilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine. The total dose will not exceed 2 mg/kg. The block is administered in addition to standard general anesthesia and multimodal analgesia. | Procedure or surgery | Erector Spinae Plane Block (ESPB), No Intervention, Paragastric Nerve Block (PGNB) |
| Active ComparatorPatients receive standard perioperative multimodal analgesia without regional anesthesia techniques. Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol. | Procedure or surgery | Erector Spinae Plane Block (ESPB), No Intervention, Paragastric Nerve Block (PGNB) |
Primary outcome
Primary Outcome
Time frame: Postoperative Hours 1, 6, 12, and 24
The primary outcome of this study is the assessment of postoperative pain levels. Pain intensity will be measured using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at the 1st, 6th, 12th, and 24th postoperative hours. The effectiveness of the analgesic techniques will be evaluated by comparing VAS scores between the groups.
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 9 Sep 2026.
- Results publication: PubMed 39944209Ul Huda A, Alshahrani AS, Yasir M, Sawilah A, Alharthi AAN. Erector spinae block reduces intraoperative and postoperative opioid consumption in patients undergoing laparoscopic sleeve gastrectomy: A randomized controlled trial. Qatar Med J. 2024 Dec 26;2024(4):58. doi: 10.5339/qmj.2024.58. eCollection 2024.
- Results publication: PubMed 38713336Katar MK, Turan UF. Efficacy and Safety of Paragastric Neural Blockade in Controlling Pain, Nausea, and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial. Obes Surg. 2024 Jul;34(7):2383-2390. doi: 10.1007/s11695-024-07255-9. Epub 2024 May 7.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains clinical information collected for the primary purpose of this single-center study. Data sharing is not planned due to institutional privacy policies and to protect participant confidentiality. Only aggregated study results will be published.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Paragastric Nerve Block (PGNB), ESPB and Active Comparator in people with Obesity Postoperative Pain and Obesity Morbid Obesity Postoperative Pain, run by Atlas University.
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 0 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ergun Gunduz, M.D., Assistant Professor (+905327448021, ergun.gunduz@atlas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: Postoperative Hours 1, 6, 12, and 24). 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 NCT07811206, which also lists 2 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 9 Sep 2026.