Knee ArthroscopyNCT07423754
Investigation of the Effects of Two Different Anaesthesia Methods Applied to Patients Scheduled for Arthroscopic Knee Surgery on the Heart
A study testing Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block and Arthroscopic Knee Surgery in people with Knee Arthroscopy and Spinal Anaesthesia, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study will include 80 patients aged 18-65 years who will undergo elective arthroscopic meniscal surgery. Patients with bleeding disorders, cardiac disease, liver and/or renal failure, arrhythmia and electrolyte imbalance, cerebrovascular disease, and those who do not wish to participate in the study will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Arthroscopy, Spinal Anaesthesia, Lumbar/Sciatic Block
- What is being tested?
- Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block and Arthroscopic Knee Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years patient
- ASA I-II status
Who cannot join
- Patients under the age of 18, over the age of 65
- Those for whom regional anaesthesia is contraindicated
- Those with known cardiac disease
- Arrhythmia
- Electrolyte imbalance,
- Liver and/or kidney failure.
- Those who do not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şanliurfa Mehmet Akif İnan Education and Research Hospital
Sanliurfa, Şanlıurfa, 63000
About this study
Official title: COMPARISON OF THE EFFECT OF LUMBAR/SCIATIC BLOCK AND SPINAL ANAESTHESIA ON THE FRONTAL QRS-T ANGLE AND INFLAMMATORY VALUES IN ARTHROSCOPIC KNEE SURGERIES
The study will include 80 patients aged 18-65 years who will undergo elective arthroscopic meniscal surgery.
Patients with bleeding disorders, cardiac disease, liver and/or renal failure, arrhythmia and electrolyte imbalance, cerebrovascular disease, and those who do not wish to participate in the study will be excluded.
Read more
Patients will be randomly assigned to two groups of 40 using a sealed envelope method; Group 1 (spinal anaesthesia administered), Group 2 (lumbar/sciatic block administered).
After obtaining informed consent from the patients, they will be taken to the operating theatre and a venous access will be established with an 18 G peripheral venous cannula. Once on the operating table, patients will be monitored and an ECG will be performed, and blood will be drawn to measure WBC, lymphocyte, neutrophil, urea, creatinine, and CRP values. Group 1 patients will receive 2 mg midazolam, 50 mcg fentanyl and spinal anaesthesia. Group 2 patients will receive 2 mg midazolam, 50 mcg fentanyl and lumbar/sciatic block.
An ECG will be performed on both groups 5 minutes after anaesthesia. Intraoperative heart rate, saturation, and blood pressure monitoring will be performed for both groups. An ECG will be performed on all patients at the end of the case. At the 6th postoperative hour, an ECG will be performed on both groups, blood samples will be taken for WBC, lymphocyte, neutrophil, urea, creatinine, and CRP values, and the first analgesia duration will be recorded.The results obtained will be statistically evaluated, and the study will be concluded. Recruiting.
Read the detailed description
The study was designed as a randomised controlled double-blind trial. Eighty patients aged 18-65 years with ASA I-II status who were scheduled for arthroscopic knee surgery were divided into two groups of 40 patients each using a sealed envelope method. Group 1 (n=40) received spinal anaesthesia, and Group 2 (n=40) received a lumbar/sciatic block. Patients under 18 years of age, over 65 years of age, those for whom regional anaesthesia is contraindicated, those with known cardiac disease, arrhythmia, electrolyte imbalance, liver and/or renal failure, and those who do not wish to participate in the study will be excluded. After obtaining informed consent from the patients, they will be taken to the operating theatre and a venous access will be established using an 18 G peripheral venous cannula. Patients undergoing surgery will undergo routine ASA monitoring (ECG, non-invasive arterial blood pressure, pulse oximetry). Group 1 patients will receive 2 mg midazolam and 50 mcg fentanyl, followed by spinal anaesthesia. The patient will be placed in a sitting position, and a spinal block will be administered by injecting 15 mg of 0.5% bupivacaine (Marcain® spinal heavy, 0.5%, 4 mL ampoule, AstraZeneca) through a 26 G spinal needle into the L3-4 intervertebral space. Sensory block will be assessed with a pinprick test, and the operation will commence once sensory block at the T10 level is achieved. Group 2 patients will receive 2 mg midazolam and 50 mcg fentanyl, and a lumbar/sciatic block will be performed under ultrasound guidance.A combined sciatic-lumbar nerve block with a total of 40 cc of 0.5% bupivacaine will be administered. The sciatic block will be performed first. For this, patients will be placed in the lateral decubitus 8 position, with the leg to be blocked on top, in the 'Sim's' position. Under ultrasound guidance, 20 cc of 0.5% bupivacaine will be injected with a 10 cm regional nerve block needle (B Braun, Melsungen, Germany) following negative aspiration. In the same position, the entry point for the lumbar block will be determined under ultrasound guidance, and 20 cc of 0.5% bupivacaine will be administered following a negative aspiration test. For surgical anaesthesia, both the sciatic and lumbar nerve distribution areas will be tested with the pinprick test to assess complete sensory block and complete motor block in the knee, ankle, and toes. Patients with adequate block quality (no need for sedoanalgesia during the operation) will be included in the study. In both groups, heart rate and mean arterial pressure will be recorded preoperatively (T1), after anaesthesia administration (T2), during surgery at 5 (T3), 15 (T4), and 30 (T5) minutes, and postoperatively (T6). ECG recordings will be obtained preoperatively, 5 minutes after anaesthesia administration, at the end of surgery, and 6 hours postoperatively. The duration of the first postoperative analgesia will be recorded for all patients. Haemogram and biochemical parameters will be assessed preoperatively, at the end of surgery, and 6 hours postoperatively.
- Conditions
- Knee Arthroscopy, Spinal Anaesthesia, Lumbar/Sciatic Block
- Being tested
- Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block, Arthroscopic Knee Surgery
- Keywords
- Spinal Anaesthesia, Knee Arthroscopy, Lumbar/Sciatic Block, Frontal QRS-T angle (f[QRS-T]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve BlockProcedure or surgery
After obtaining informed consent, patients are taken to the operating room, and venous access will be established with an 18-gauge peripheral venous cannula. Routine ASA monitoring (ECG, noninvasive arterial blood pressure, pulse oximetry) will be performed on patients undergoing surgery. Group 1 patients will receive spinal anesthesia following the administration of 2 mg midazolam and 50 mcg fentanyl. A spinal block will be performed with 15 mg of 0.5% bupivacaine (Marcain® spinal heavy, 0.5%, 4 mL ampoule, AstraZeneca) administered through a 26-gauge spinal needle at the L3-4 intervertebral space, with the patient in a sitting position. Sensory blockade will be assessed with a pinprick test, and surgery will begin once sensory blockade is achieved at the T10 level.
Arthroscopic Knee SurgeryProcedure or surgery
After obtaining informed consent, patients will be taken to the operating room, and venous access will be established with an 18-gauge peripheral venous cannula. Routine ASA monitoring (ECG, noninvasive arterial blood pressure, pulse oximetry) will be performed on patients undergoing surgery.Group 2 patients will receive 2 mg midazolam and 50 mcg fentanyl, followed by an ultrasound-guided lumbar/sciatic block. A combined sciatic-lumbar nerve block will be administered with a total of 40 cc of 0.5% bupivacaine. The sciatic block will begin with the patient. Patients will be placed in the lateral decubitus 8 position, with the leg to be blocked elevated. Following a negative aspiration, 20 cc of 0.5% bupivacaine will be injected using a 10-cm regional nerve block needle (B Braun, Melsungen, Germany) guided by ultrasound. In the same position, the entry point for the lumbar block will be determined under ultrasound guidance, and following a negative aspiration test, 20 cc of 0.5% bupivaca
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia | Active comparator | Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia Receives: Procedure: Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block |
| Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block | Experimental | Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block Receives: Procedure: Arthroscopic Knee Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
In our study, we aimed to compare the effects of lumbar/sciatic block and spinal anaesthesia on the QRS-T interval in the electrocardiogram in patients undergoing arthroscopic knee meniscectomy.
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Sep 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies 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
- The study was designed as a randomised controlled double-blind trial. Eighty patients aged 18-65 years with ASA I-II status, scheduled for arthroscopic knee surgery, will be randomly assigned to two groups of 40 patients each using a sealed envelope method. Group 1 (n=40) will receive spinal anaesthesia, and Group 2 (n=40) will receive a lumbar/sciatic block.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Bingöl Tanriverdi, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423754
- Sponsor's protocol ID
- HRÜ/25.03.56
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECT OF LUMBAR/SCIATIC BLOCK AND SPINAL ANAESTHESIA ON THE FRONTAL QRS-T ANGLE AND INFLAMMATORY VALUES IN ARTHROSCOPIC KNEE SURGERIES
- ClinicalTrials.gov ID
- NCT07423754
- Acronym / sponsor ID
- HRÜ/25.03.56
- Conditions
- Knee Arthroscopy, Spinal Anaesthesia, Lumbar/Sciatic Block
- Keywords
- Spinal Anaesthesia, Knee Arthroscopy, Lumbar/Sciatic Block, Frontal QRS-T angle (f[QRS-T]
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 20 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.
The study will include 80 patients aged 18-65 years who will undergo elective arthroscopic meniscal surgery.
Patients with bleeding disorders, cardiac disease, liver and/or renal failure, arrhythmia and electrolyte imbalance, cerebrovascular disease, and those who do not wish to participate in the study will be excluded.
Patients will be randomly assigned to two groups of 40 using a sealed envelope method; Group 1 (spinal anaesthesia administered), Group 2 (lumbar/sciatic block administered).
After obtaining informed consent from the patients, they will be taken to the operating theatre and a venous access will be established with an 18 G peripheral venous cannula. Once on the operating table, patients will be monitored and an ECG will be performed, and blood will be drawn to measure WBC, lymphocyte, neutrophil, urea, creatinine, and CRP values. Group 1 patients will receive 2 mg midazolam, 50 mcg fentanyl and spinal anaesthesia. Group 2 patients will receive 2 mg midazolam, 50 mcg fentanyl and lumbar/sciatic block.
An ECG will be performed on both groups 5 minutes after anaesthesia. Intraoperative heart rate, saturation, and blood pressure monitoring will be performed for both groups. An ECG will be performed on all patients at the end of the case. At the 6th postoperative hour, an ECG will be performed on both groups, blood samples will be taken for WBC, lymphocyte, neutrophil, urea, creatinine, and CRP values, and the first analgesia duration will be recorded.The results obtained will be statistically evaluated, and the study will be concluded. Recruiting.
Detailed description
The study was designed as a randomised controlled double-blind trial. Eighty patients aged 18-65 years with ASA I-II status who were scheduled for arthroscopic knee surgery were divided into two groups of 40 patients each using a sealed envelope method. Group 1 (n=40) received spinal anaesthesia, and Group 2 (n=40) received a lumbar/sciatic block. Patients under 18 years of age, over 65 years of age, those for whom regional anaesthesia is contraindicated, those with known cardiac disease, arrhythmia, electrolyte imbalance, liver and/or renal failure, and those who do not wish to participate in the study will be excluded. After obtaining informed consent from the patients, they will be taken to the operating theatre and a venous access will be established using an 18 G peripheral venous cannula. Patients undergoing surgery will undergo routine ASA monitoring (ECG, non-invasive arterial blood pressure, pulse oximetry). Group 1 patients will receive 2 mg midazolam and 50 mcg fentanyl, followed by spinal anaesthesia. The patient will be placed in a sitting position, and a spinal block will be administered by injecting 15 mg of 0.5% bupivacaine (Marcain® spinal heavy, 0.5%, 4 mL ampoule, AstraZeneca) through a 26 G spinal needle into the L3-4 intervertebral space. Sensory block will be assessed with a pinprick test, and the operation will commence once sensory block at the T10 level is achieved. Group 2 patients will receive 2 mg midazolam and 50 mcg fentanyl, and a lumbar/sciatic block will be performed under ultrasound guidance.A combined sciatic-lumbar nerve block with a total of 40 cc of 0.5% bupivacaine will be administered. The sciatic block will be performed first. For this, patients will be placed in the lateral decubitus 8 position, with the leg to be blocked on top, in the 'Sim's' position. Under ultrasound guidance, 20 cc of 0.5% bupivacaine will be injected with a 10 cm regional nerve block needle (B Braun, Melsungen, Germany) following negative aspiration. In the same position, the entry point for the lumbar block will be determined under ultrasound guidance, and 20 cc of 0.5% bupivacaine will be administered following a negative aspiration test. For surgical anaesthesia, both the sciatic and lumbar nerve distribution areas will be tested with the pinprick test to assess complete sensory block and complete motor block in the knee, ankle, and toes. Patients with adequate block quality (no need for sedoanalgesia during the operation) will be included in the study. In both groups, heart rate and mean arterial pressure will be recorded preoperatively (T1), after anaesthesia administration (T2), during surgery at 5 (T3), 15 (T4), and 30 (T5) minutes, and postoperatively (T6). ECG recordings will be obtained preoperatively, 5 minutes after anaesthesia administration, at the end of surgery, and 6 hours postoperatively. The duration of the first postoperative analgesia will be recorded for all patients. Haemogram and biochemical parameters will be assessed preoperatively, at the end of surgery, and 6 hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was designed as a randomised controlled double-blind trial. Eighty patients aged 18-65 years with ASA I-II status, scheduled for arthroscopic knee surgery, will be randomly assigned to two groups of 40 patients each using a sealed envelope method. Group 1 (n=40) will receive spinal anaesthesia, and Group 2 (n=40) will receive a lumbar/sciatic block.
| Arm | Type | Receives |
|---|---|---|
| Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia | Active comparator | Procedure: Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve BlockGroup 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia |
| Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block | Experimental | Procedure: Arthroscopic Knee SurgeryGroup 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years patient
- ASA I-II status
Key exclusion criteria (7 listed)
- Patients under the age of 18, over the age of 65
- Those for whom regional anaesthesia is contraindicated
- Those with known cardiac disease
- Arrhythmia
- Electrolyte imbalance,
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 |
|---|---|---|
| Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve BlockAfter obtaining informed consent, patients are taken to the operating room, and venous access will be established with an 18-gauge peripheral venous cannula. Routine ASA monitoring (ECG, noninvasive arterial blood pressure, pulse oximetry) will be performed on patients undergoing surgery. Group 1 patients will receive spinal anesthesia following the administration of 2 mg midazolam and 50 mcg fentanyl. A spinal block will be performed with 15 mg of 0.5% bupivacaine (Marcain® spinal heavy, 0.5%, 4 mL ampoule, AstraZeneca) administered through a 26-gauge spinal needle at the L3-4 intervertebral space, with the patient in a sitting position. Sensory blockade will be assessed with a pinprick test, and surgery will begin once sensory blockade is achieved at the T10 level. | Procedure or surgery | Group 1: 40 patients undergoing knee arthroscopy with spinal anaesthesia |
| Arthroscopic Knee SurgeryAfter obtaining informed consent, patients will be taken to the operating room, and venous access will be established with an 18-gauge peripheral venous cannula. Routine ASA monitoring (ECG, noninvasive arterial blood pressure, pulse oximetry) will be performed on patients undergoing surgery.Group 2 patients will receive 2 mg midazolam and 50 mcg fentanyl, followed by an ultrasound-guided lumbar/sciatic block. A combined sciatic-lumbar nerve block will be administered with a total of 40 cc of 0.5% bupivacaine. The sciatic block will begin with the patient. Patients will be placed in the lateral decubitus 8 position, with the leg to be blocked elevated. Following a negative aspiration, 20 cc of 0.5% bupivacaine will be injected using a 10-cm regional nerve block needle (B Braun, Melsungen, Germany) guided by ultrasound. In the same position, the entry point for the lumbar block will be determined under ultrasound guidance, and following a negative aspiration test, 20 cc of 0.5% bupivaca | Procedure or surgery | Group 2: 40 patients undergoing knee arthroscopy with lumbar/sciatic block |
Primary outcome
In our study, we aimed to compare the effects of lumbar/sciatic block and spinal anaesthesia on the QRS-T interval in the electrocardiogram in patients undergoing arthroscopic knee meniscectomy.
Time frame: From enrollment to the end of treatment at 10 weeks
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 20 Feb 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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 Knee Arthroscopy, Spinal Anaesthesia, Peripheral Nerve Block and Arthroscopic Knee Surgery in people with Knee Arthroscopy and Spinal Anaesthesia, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital 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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 20 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?
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?
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?
In our study, we aimed to compare the effects of lumbar/sciatic block and spinal anaesthesia on the QRS-T interval in the electrocardiogram in patients undergoing arthroscopic knee meniscectomy. (time frame: From enrollment to the end of treatment at 10 weeks). 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 20 Feb 2026.