Opioid ConsumptionNCT05618210
Effect of ESPB and Rhomboid Block on VATS Method
A study testing regional anesthesia in people with Opioid Consumption and Postoperative Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Consumption, Postoperative Pain, Complication,Postoperative
- What is being tested?
- regional anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 15 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years, ASA 1-2-3 who gave informed consent
Who cannot join
- Patients with contraindications, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, infection at the injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of ESPB and Rhomboid Block on Postoperative Pain and Opioid Consumption in Patients Undergoing Lobectomy With VATS Method: a Randomized Controlled Study
The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in this study. Patients with contraindications for the application of either method, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, and infection at the injection site will not be included in the study. Patients who agree to participate in the study will be randomly assigned to one of the anesthesia groups of the study, which include ESPB (elector spina plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1 and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn randomly for each patient before the procedure, and procedures will be carried out according to the group specified on the paper.
Read the detailed description
Video-assisted thoracic surgery (VATS); Although it causes less postoperative pain compared to traditional thoracotomy, it can still cause significant postoperative problems. Relief of postoperative pain; it eliminates the undesirable pathological effects of pain, reduces the length of hospital stay and costs. Thoracic epidural analgesia and paravertebral block are recommended for the relief of postoperative pain after thoracotomy. Bendixen et al. Because VATS is less painful; recommended less invasive regional techniques and systemic analgesics. For the relief of postoperative pain after VATS; paravertebral block, erector spina plan block (ESPB), and serratus plan block have been successfully applied. In order to provide analgesia after VATS; the most appropriate techniques or protocols need to be determined. ESPB; In 2016, Forero et al. and is used for the control of pain after many surgical procedures. ESPB has been successfully applied for the relief of postoperative pain after VATS. Elsharkawy et al. have shown that rhomboid intercostal block can be beneficial in providing adequate analgesia for both anterior and posterior hemithorax, in cadaver studies, but it is better with methods that are useful in relieving pain after VATS previously. They say more comparisons are needed. In recent studies, it has been shown that rhomboid intercostal block is effective in relieving postoperative pain in comparison with control groups. More randomized controlled studies are needed to demonstrate that rhomboid intercostal block provides effective analgesia in VATS. The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.
The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in this study. Patients with contraindications for the application of either method, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, and infection at the injection site will not be included in the study. Patients who agree to participate in the study will be randomly assigned to one of the anesthesia groups of the study, which include ESPB (elector spina plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1 and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn randomly for each patient before the procedure, and procedures will be carried out according to the group specified on the paper.
Intraoperative anesthesia management The patients in this group were on the operating table before induction of anesthesia, and in the ESPB group (Group 1), after the patients were placed in the prone position, the linear ultrasound probe was placed in the midline in the transverse plane, and spinous processes were visualized at the T5 vertebra level, and the transverse process, trapezius, latissimus dorsi and erector spina muscles were visualized on the side where VATS was planned. will be displayed. With an 'in-plane' approach, using a 22 gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly.
In the rhomboid intercostal block group (Group 2), after the patients are placed in the prone position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm needle will be injected into the plan between them at the T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.
Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol (2 mg/kg), remifentanil 1mcg/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be started immediately after intubation. Anesthesia will be maintained with remifentanil infusion, with ANI > 50 and BIS < 50. Patients were given 1 g i.v. before waking up after surgery. paracetamol will be given. Measurements Perioperative clinical and demographic data of each patient will be collected: age, gender, diagnosis, operation, ASA, duration of surgery, duration of anesthesia. Intraoperatively, heart rate, blood pressure, ANI and BIS measurements will be made and recorded in all patients at 15-minute intervals. The total intraoperative opioid dose will also be recorded.
Post-awakening pain will be assessed and recorded using the visual analog scale (VAS), then patient-controlled analgesia (PCA) will be initiated, with all patients locked in 15 minutes and given 4 mg of morphine at each application by the patient. Pain assessment will be done with VAS at 6, 12, 24 and 48 hours postoperatively. In the postoperative period, the amount of morphine administered by PCA (in the first and second 24 hours) and any additional analgesics required (tramadol, paracetamol, etc.) will be recorded.
sample size In a previous study, based on the consumption of morphine equivalent in the first 24 hours (approximately 2.75 mg standard deviation) [8], it was found that 33 patients per group were required to detect the 2.5 mg difference between the two groups with 90% power and 5% alpha error. . Considering that there may be a dropout of approximately 10 percent, it is planned to include at least 35 patients in each group.
Statistical analysis In the comparison of the two groups in terms of continuous numerical variables, Student t test or Mann-Whitney U test will be used for independent samples according to distribution. Groups will be compared in terms of categorical variables using the Pearson chi-square test or the Fisher exact test. Two-way ANOVA test will be used for repeated measurements in comparison of groups in terms of the course of postoperative VAS scores and intraoperative heart rate, blood pressure, ANI, BIS variables over time. A value of p<0.05 will be accepted as an indicator of significance in the tests.
- Being tested
- regional anesthesia
- Keywords
- ESPB, RHOMBOİD BLOCK, OPİOİD, POSTOPERATİVE PAIN
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesiaOther
in the ESPB group, the linear ultrasound probe was placed in the erector spina muscles were visualized on the side where VATS was planned. block needle can be seen on ultrasound, the skin and erector spina muscles are passed in the cranio-caudal direction. ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly.
In the rhomboid intercostal block group, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block group | Active comparator | In the ESPB group, after the patients are placed in the prone position, the linear ultrasound probe will be placed in the midline in the transverse plane to visualize the spinous processes, and the transverse process, trapezius, latissimus dorsi and erector spina muscles will be visualized on the side where VATS is planned at the T5 vertebra level. With an 'in-plane' approach, using a 22 gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly. Receives: Other: regional anesthesia |
| Rhomboid block | Active comparator | In the rhomboid intercostal block group, after the patients are placed in the prone position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm needle will be injected into the plan between them at the T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection. Receives: Other: regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain management
record of postoperative visual analog scala 0-10 values
Measured: postoperatif first 24 hours.
Secondary outcomes (1)
opioid consumption
record of postoperative opioid consumption with patients control device
Measured: postoperatif first 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start15 Jun 2022
- Primary completion26 Oct 2023
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid ConsumptionStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Orhon, Marmara University
- Investigators
- MELIHA ORHON ERGUN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618210
- Sponsor's protocol ID
- 09.2022.756
- Status last verified
- Feb 2026
- First submitted
- 8 Nov 2022
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of ESPB and Rhomboid Block on Postoperative Pain and Opioid Consumption in Patients Undergoing Lobectomy With VATS Method: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05618210
- Acronym / sponsor ID
- 09.2022.756
- Keywords
- ESPB, RHOMBOİD BLOCK, OPİOİD, POSTOPERATİVE PAIN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 16 Nov 2022 (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.
The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in this study. Patients with contraindications for the application of either method, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, and infection at the injection site will not be included in the study. Patients who agree to participate in the study will be randomly assigned to one of the anesthesia groups of the study, which include ESPB (elector spina plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1 and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn randomly for each patient before the procedure, and procedures will be carried out according to the group specified on the paper.
Detailed description
Video-assisted thoracic surgery (VATS); Although it causes less postoperative pain compared to traditional thoracotomy, it can still cause significant postoperative problems. Relief of postoperative pain; it eliminates the undesirable pathological effects of pain, reduces the length of hospital stay and costs. Thoracic epidural analgesia and paravertebral block are recommended for the relief of postoperative pain after thoracotomy. Bendixen et al. Because VATS is less painful; recommended less invasive regional techniques and systemic analgesics. For the relief of postoperative pain after VATS; paravertebral block, erector spina plan block (ESPB), and serratus plan block have been successfully applied. In order to provide analgesia after VATS; the most appropriate techniques or protocols need to be determined. ESPB; In 2016, Forero et al. and is used for the control of pain after many surgical procedures. ESPB has been successfully applied for the relief of postoperative pain after VATS. Elsharkawy et al. have shown that rhomboid intercostal block can be beneficial in providing adequate analgesia for both anterior and posterior hemithorax, in cadaver studies, but it is better with methods that are useful in relieving pain after VATS previously. They say more comparisons are needed. In recent studies, it has been shown that rhomboid intercostal block is effective in relieving postoperative pain in comparison with control groups. More randomized controlled studies are needed to demonstrate that rhomboid intercostal block provides effective analgesia in VATS. The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.
The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in this study. Patients with contraindications for the application of either method, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, and infection at the injection site will not be included in the study. Patients who agree to participate in the study will be randomly assigned to one of the anesthesia groups of the study, which include ESPB (elector spina plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1 and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn randomly for each patient before the procedure, and procedures will be carried out according to the group specified on the paper.
Intraoperative anesthesia management The patients in this group were on the operating table before induction of anesthesia, and in the ESPB group (Group 1), after the patients were placed in the prone position, the linear ultrasound probe was placed in the midline in the transverse plane, and spinous processes were visualized at the T5 vertebra level, and the transverse process, trapezius, latissimus dorsi and erector spina muscles were visualized on the side where VATS was planned. will be displayed. With an 'in-plane' approach, using a 22 gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly.
In the rhomboid intercostal block group (Group 2), after the patients are placed in the prone position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm needle will be injected into the plan between them at the T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.
Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol (2 mg/kg), remifentanil 1mcg/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be started immediately after intubation. Anesthesia will be maintained with remifentanil infusion, with ANI > 50 and BIS < 50. Patients were given 1 g i.v. before waking up after surgery. paracetamol will be given. Measurements Perioperative clinical and demographic data of each patient will be collected: age, gender, diagnosis, operation, ASA, duration of surgery, duration of anesthesia. Intraoperatively, heart rate, blood pressure, ANI and BIS measurements will be made and recorded in all patients at 15-minute intervals. The total intraoperative opioid dose will also be recorded.
Post-awakening pain will be assessed and recorded using the visual analog scale (VAS), then patient-controlled analgesia (PCA) will be initiated, with all patients locked in 15 minutes and given 4 mg of morphine at each application by the patient. Pain assessment will be done with VAS at 6, 12, 24 and 48 hours postoperatively. In the postoperative period, the amount of morphine administered by PCA (in the first and second 24 hours) and any additional analgesics required (tramadol, paracetamol, etc.) will be recorded.
sample size In a previous study, based on the consumption of morphine equivalent in the first 24 hours (approximately 2.75 mg standard deviation) [8], it was found that 33 patients per group were required to detect the 2.5 mg difference between the two groups with 90% power and 5% alpha error. . Considering that there may be a dropout of approximately 10 percent, it is planned to include at least 35 patients in each group.
Statistical analysis In the comparison of the two groups in terms of continuous numerical variables, Student t test or Mann-Whitney U test will be used for independent samples according to distribution. Groups will be compared in terms of categorical variables using the Pearson chi-square test or the Fisher exact test. Two-way ANOVA test will be used for repeated measurements in comparison of groups in terms of the course of postoperative VAS scores and intraoperative heart rate, blood pressure, ANI, BIS variables over time. A value of p<0.05 will be accepted as an indicator of significance in the tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block group | Active comparator | Other: regional anesthesiaIn the ESPB group, after the patients are placed in the prone position, the linear ultrasound probe will be placed in the midline in the transverse plane to visualize the spinous processes, and the transverse process, trapezius, latissimus dorsi and erector spina muscles will be visualized on the side where VATS is planned at the T5 vertebra level. With an 'in-plane' approach, using a 22 gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly. |
| Rhomboid block | Active comparator | Other: regional anesthesiaIn the rhomboid intercostal block group, after the patients are placed in the prone position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm needle will be injected into the plan between them at the T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-75 years, ASA 1-2-3 who gave informed consent
Key exclusion criteria (1 listed)
- Patients with contraindications, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, infection at the injection site
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 |
|---|---|---|
| regional anesthesiain the ESPB group, the linear ultrasound probe was placed in the erector spina muscles were visualized on the side where VATS was planned. block needle can be seen on ultrasound, the skin and erector spina muscles are passed in the cranio-caudal direction. ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly. In the rhomboid intercostal block group, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection. | Other | Rhomboid block, erector spinae plane block group |
Primary outcome
postoperative pain management
Time frame: postoperatif first 24 hours.
record of postoperative visual analog scala 0-10 values
1 secondary outcome
opioid consumption
Time frame: postoperatif first 24 hours.
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 18 Feb 2026.
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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.
MELIHA ORHON ERGUN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional anesthesia in people with Opioid Consumption and Postoperative Pain, run by Marmara 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: finished, as of the sponsor's last update on 18 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. 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?
postoperative pain management (time frame: postoperatif first 24 hours.). 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 18 Feb 2026.