AnesthesiaNCT05822492
Anterior Quadratus Lumborum Block Versus Erector Spina Plane Block in Percutaneous Nephrolithotomy Surgery
An observational study of Anesthesia and Analgesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to evaluate the effects of anterior quadratus lumborum block (QLB3) and Erector Spina Plane Block (ESPB) on postoperative acute pain scores and opioid consumption in the first 24 hours in Percutaneous Nephrolithotomy Surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Analgesia, Patient Controlled Analgesia
- What is being tested?
- Group QLB3 and Group ESPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 30 Sep 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with undergoing percutaneous nephrolithotomy surgery,
Who may be able to join
- 18-65 years
- American Society of Anesthesiology score I-III patients scheduled for unilateral PCNL in elective conditions
- Patients with BMI <35 kg/m2
Who cannot join
- Pregnancy
- Conditions where regional anesthesia is contraindicated (coagulopathy, international normalized ratio abnormality, thrombocytopenia, infection at the injection site)
- History of hypersensitivity or allergy to local anesthetics
- Patients with psychiatric disorders
- Patients with musculoskeletal deformities
- Patients with alcohol-drug dependence
- Patients with cognitive dysfunction (patients incapable of evaluating the NRS score)
- Patients who did not give consent / did not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Anterior Quadratus Lumborum Block and Erector Spina Plane Block on Postoperative Acute Pain in Percutaneous Nephrolithotomy Surgery
In this study, it was aimed to evaluate the effects of anterior quadratus lumborum block (QLB3) and Erector Spina Plane Block (ESPB) on postoperative acute pain scores and opioid consumption in the first 24 hours in Percutaneous Nephrolithotomy Surgery
Read the detailed description
Percutaneous nephrolithotomy (PCNL) is commonly used to treat large kidney stones. Patients usually complain of severe pain and discomfort postoperatively. Postoperative pain prolongs hospital stay, delays wound healing, increases infection rates, and increases the incidence of drug side effects.
Regional anesthesia is part of multimodal analgesia in treating postoperative pain. Facial plane blocks are among these procedures. Erector spina plane block (ESPB) is a peri-paravertebral regional anesthesia technique applied for the first time to treat thoracic neuropathic pain. In the literature, the effectiveness of upper abdomen and renal operations in pain management has been demonstrated. Quadratus lumborum block (QLB) was first described as an alternative to the transversus abdominis plane block. This block can be performed with three methods under ultrasound guidance. An anterior QLB (QLB3) block was used in this study. In this block, the local anesthetic drug is applied between the quadratus lumborum muscle and the psoas muscle fascia and spreads along the thoracolumbar fascia. This block provides anesthesia and analgesia in the T7-L1 dermatome area. QLB3 block has been applied in pyeloplasty, cholecystectomy, lower abdominal surgeries, cesarean sections, radical nephrectomy, and hip joint surgeries and provided adequate postoperative analgesia.
This study aimed to evaluate the effects of QLB3 block and ESPB block on pain scores and opioid consumption in patients undergoing PCNL.
Patients will be divided into three groups.
Group QLB3:
Patients who applied the OLB3 block and IV morphine-patient-controlled analgesia (PCA) before PCNL surgery were included in this group.
Group ESPB:
Patients who applied ESPB block and IV morphine-PCA before PCNL surgery were included in this group.
Group Control In this group, patients only applied general anesthesia and IV morphine-PCA.
- Conditions
- Anesthesia, Analgesia, Patient Controlled Analgesia, Quadratus Lumborum Block, Erector Spina Plane Block
- Being tested
- Group QLB3, Group ESPB, Group Control
- Keywords
- Anesthesia, Analgesia, Percutaneous Nephrolithotomy Surgery, Patient controlled analgesia, Anterior quadratus lumborum block, Erector spina plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group QLB3Procedure or surgery
Also called Anterior Quadratus Lumborum Block (QLB3)
Patients who applied the QLB3 block before PCNL surgery were included in this group
Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.
Group ESPBProcedure or surgery
Also called Erector spina plane block (ESPB)
Patients who applied ESP block before PCNL surgery were included in this group
Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.
Group ControlOther
Also called Control
Patients who did not use block before PCNL surgery were included in this group.
Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group QLB3 | Patients who applied the QLB3 block before PCNL surgery were included in this group. Receives: Procedure: Group QLB3 | |
| Group ESPB | Patients who applied ESP block before PCNL surgery were included in this group. Receives: Procedure: Group ESPB | |
| Group Control | Patients who did not use any block before PCNL surgery were included in this group. Receives: Other: Group Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in the first 24 hours after surgery
Morphine consumption in the first 24 hours after surgery will be measured. Patients will be able to request opioids via a PCA device when their NRS score is ≥ 4.
Measured: postoperative day 1
Secondary outcomes (8)
Postoperative pain scores
Pain status at rest and while activity will be assessed by numeric rating scale (NRS) score at 0, 3, 6, 12, 18, and 24 hours after surgery. In addition, the time until the first analgesic requirement will be recorded. The NRS is an 11-point numeric scale that ranges from 0 to 10.
Measured: postoperative day 1
The postoperative nausea and vomiting (PONV) scores and the number of patients requiring antiemetic medication.
The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Measured: postoperative day 1
Intraoperative remifentanil consumption
The total amount of remifentanil consumed will be recorded.
Measured: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
The number of patient required rescue analgesia
The number of patients requiring rescue analgesics will be recorded over 24 hours.
Measured: postoperative day 1
Time of first analgesic request
Time at which the first analgesic is requested
Measured: postoperative day 1
The number of patients with complications
The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded
Measured: Postoperative 7 days on an average
The mean arterial pressure
The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.
Measured: The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
The heart rate measurement
The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.
Measured: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start20 Apr 2023
- Primary completion20 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz KAYA, Ondokuz Mayıs University
- Investigators
- CENGIZ KAYA, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822492
- Sponsor's protocol ID
- PNLESPQLB2022
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. doi: 10.1016/j.bja.2019.04.054. Epub 2019 May 30.
PubMed 31153628Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.
PubMed 28277325De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
PubMed 30621377Elsharkawy H. Quadratus Lumborum Blocks. Adv Anesth. 2017;35(1):145-157. doi: 10.1016/j.aan.2017.07.007. Epub 2017 Oct 3. No abstract available.
PubMed 29103570Kilic E, Bulut E. Quadratus Lumborum Block III for Postoperative Pain After Percutaneous Nephrolithotomy. Turk J Anaesthesiol Reanim. 2018 Aug;46(4):272-275. doi: 10.5152/TJAR.2018.92331. Epub 2018 Aug 1.
PubMed 30140533Turkan H, Kaya C, Turunc E, Dost B, Ustun YB. Effects of anterior quadratus lumborum block versus erector spinae plane block on postoperative acute pain in percutaneous nephrolithotomy: a prospective, observational study. BMC Anesthesiol. 2024 Sep 10;24(1):322. doi: 10.1186/s12871-024-02691-7.
PubMed 39256675
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Anterior Quadratus Lumborum Block and Erector Spina Plane Block on Postoperative Acute Pain in Percutaneous Nephrolithotomy Surgery
- ClinicalTrials.gov ID
- NCT05822492
- Acronym / sponsor ID
- PNLESPQLB2022
- Conditions
- Anesthesia, Analgesia, Patient Controlled Analgesia, Quadratus Lumborum Block, Erector Spina Plane Block
- Keywords
- Anesthesia, Analgesia, Percutaneous Nephrolithotomy Surgery, Patient controlled analgesia, Anterior quadratus lumborum block, Erector spina plane block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Apr 2023 (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.
In this study, it was aimed to evaluate the effects of anterior quadratus lumborum block (QLB3) and Erector Spina Plane Block (ESPB) on postoperative acute pain scores and opioid consumption in the first 24 hours in Percutaneous Nephrolithotomy Surgery
Detailed description
Percutaneous nephrolithotomy (PCNL) is commonly used to treat large kidney stones. Patients usually complain of severe pain and discomfort postoperatively. Postoperative pain prolongs hospital stay, delays wound healing, increases infection rates, and increases the incidence of drug side effects.
Regional anesthesia is part of multimodal analgesia in treating postoperative pain. Facial plane blocks are among these procedures. Erector spina plane block (ESPB) is a peri-paravertebral regional anesthesia technique applied for the first time to treat thoracic neuropathic pain. In the literature, the effectiveness of upper abdomen and renal operations in pain management has been demonstrated. Quadratus lumborum block (QLB) was first described as an alternative to the transversus abdominis plane block. This block can be performed with three methods under ultrasound guidance. An anterior QLB (QLB3) block was used in this study. In this block, the local anesthetic drug is applied between the quadratus lumborum muscle and the psoas muscle fascia and spreads along the thoracolumbar fascia. This block provides anesthesia and analgesia in the T7-L1 dermatome area. QLB3 block has been applied in pyeloplasty, cholecystectomy, lower abdominal surgeries, cesarean sections, radical nephrectomy, and hip joint surgeries and provided adequate postoperative analgesia.
This study aimed to evaluate the effects of QLB3 block and ESPB block on pain scores and opioid consumption in patients undergoing PCNL.
Patients will be divided into three groups.
Group QLB3:
Patients who applied the OLB3 block and IV morphine-patient-controlled analgesia (PCA) before PCNL surgery were included in this group.
Group ESPB:
Patients who applied ESPB block and IV morphine-PCA before PCNL surgery were included in this group.
Group Control In this group, patients only applied general anesthesia and IV morphine-PCA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group QLB3 | – | Procedure: Group QLB3Patients who applied the QLB3 block before PCNL surgery were included in this group. |
| Group ESPB | – | Procedure: Group ESPBPatients who applied ESP block before PCNL surgery were included in this group. |
| Group Control | – | Other: Group ControlPatients who did not use any block before PCNL surgery were included in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with undergoing percutaneous nephrolithotomy surgery,
Key inclusion criteria (3 listed)
- 18-65 years
- American Society of Anesthesiology score I-III patients scheduled for unilateral PCNL in elective conditions
- Patients with BMI <35 kg/m2
Key exclusion criteria (8 listed)
- Pregnancy
- Conditions where regional anesthesia is contraindicated (coagulopathy, international normalized ratio abnormality, thrombocytopenia, infection at the injection site)
- History of hypersensitivity or allergy to local anesthetics
- Patients with psychiatric disorders
- Patients with musculoskeletal deformities
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 |
|---|---|---|
| Group QLB3Also: Anterior Quadratus Lumborum Block (QLB3)Patients who applied the QLB3 block before PCNL surgery were included in this group Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure. | Procedure or surgery | Group QLB3 |
| Group ESPBAlso: Erector spina plane block (ESPB)Patients who applied ESP block before PCNL surgery were included in this group Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure. | Procedure or surgery | Group ESPB |
| Group ControlAlso: ControlPatients who did not use block before PCNL surgery were included in this group. Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure. | Other | Group Control |
Primary outcome
Morphine consumption in the first 24 hours after surgery
Time frame: postoperative day 1
Morphine consumption in the first 24 hours after surgery will be measured. Patients will be able to request opioids via a PCA device when their NRS score is ≥ 4.
8 secondary outcomes
Postoperative pain scores
Time frame: postoperative day 1
The postoperative nausea and vomiting (PONV) scores and the number of patients requiring antiemetic medication.
Time frame: postoperative day 1
Intraoperative remifentanil consumption
Time frame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
The number of patient required rescue analgesia
Time frame: postoperative day 1
Time of first analgesic request
Time frame: postoperative day 1
The number of patients with complications
Time frame: Postoperative 7 days on an average
The mean arterial pressure
Time frame: The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
The heart rate measurement
Time frame: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
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 8 Dec 2023.
- Background: PubMed 31153628Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. doi: 10.1016/j.bja.2019.04.054. Epub 2019 May 30.
- Background: PubMed 28277325Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.
- Background: PubMed 30621377De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
- Background: PubMed 29103570Elsharkawy H. Quadratus Lumborum Blocks. Adv Anesth. 2017;35(1):145-157. doi: 10.1016/j.aan.2017.07.007. Epub 2017 Oct 3. No abstract available.
- Background: PubMed 30140533Kilic E, Bulut E. Quadratus Lumborum Block III for Postoperative Pain After Percutaneous Nephrolithotomy. Turk J Anaesthesiol Reanim. 2018 Aug;46(4):272-275. doi: 10.5152/TJAR.2018.92331. Epub 2018 Aug 1.
- Derived from this study: PubMed 39256675Turkan H, Kaya C, Turunc E, Dost B, Ustun YB. Effects of anterior quadratus lumborum block versus erector spinae plane block on postoperative acute pain in percutaneous nephrolithotomy: a prospective, observational study. BMC Anesthesiol. 2024 Sep 10;24(1):322. doi: 10.1186/s12871-024-02691-7.
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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.
CENGIZ KAYA study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Analgesia, run by Ondokuz Mayıs 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 3 inclusion and 8 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 8 Dec 2023. 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?
Morphine consumption in the first 24 hours after surgery (time frame: postoperative day 1). 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 NCT05822492, which also lists 6 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 8 Dec 2023.