Tourniquet PainNCT06942650
The Effect of Prolonged ischemıa and anesthetıc Agents on Oxidative Stress
An observational study of Tourniquet Pain and Ischemia-reperfusion, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced oxidative damage in adults undergoing orthopedic knee arthroscopy surgery.The goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourniquet Pain, Ischemia-reperfusion, Postoperative Pain
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Aug 2024
- How long will I take part?
- 1 Day
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixty patients aged 18-80, with ASA I-II status, who underwent knee arthroscopy were included in the study. A voluntary consent form was obtained all th e patients.
Who may be able to join
- Patients aged 18-80 years,
- (American society of Anesthesiologist) ASA I-II status,
- undergoing knee arthroscopy.
Who cannot join
- Diabetes mellitus,
- advanced chronic obstructive pulmonary disease,
- liver failure,
- renal failure,
- history of previous bypass,
- hemoglobinopathies,
Show all 9Show fewer
- anemia,
- hypertensive patients,
- neurodegenerative diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prolonged ischemıa and Anesthetic Agents on oxıdatıve Stress Parameters, postoperatıve Pain, and Postoperative Analgesia Requirement
The goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced oxidative damage in adults undergoing orthopedic knee arthroscopy surgery.The goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced oxidative damage in adults undergoing orthopedic knee arthroscopy surgery.
The main question it aims to answer is:
Does anesthetic agents used will affect tourniquet-related oxidative stress and postoperative pain ?
Read the detailed description
Approval was received from Duzce University Clinical Research Ethics Committee(Decision no: 2019/02). Düzce University Among the patients who applied to the Orthopaedics Clinic of Düzce University Medical Faculty, Research and Application Hospital's Orthopaedics Clinic, and planned a knee arthroscopy operation, 60 patients with ASA I-II status who accepted participation and signed the informed consent were included in the study after receiving general anaesthesia. 1 patient was excluded from the study in the analysis part. The results of a total of 59 patients were analysed.
Patients underwent routine anaesthetic examination during preoperative preparation. Informed consent was obtained from all patients. All patients were pressurised at a 90-degree angle to the knee with an algometer (J Tech Commender Echo Algometer, USA), and the average of three measurements was taken. The pressure was displayed in grams (gr) on the digital screen on the front of the devices. The first pressure value at which the patient felt pain was recorded in gr. Measurements were made at three levels (lower, middle, upper) 3-4 cm from the incision site. Measurements around the incision site
Patients were prepared for the operation according to the timing and conditions planned by the relevant clinic, and no preoperative or operative interventions were made regarding the method of operation or anesthesia. The oxidative load (HIF and DAF-16) [ Human hypoxia-inducible factor 1α(HIF-1α) ELISA kit (pg/L), Human decay-accelerating factor(DAF/CD55)ELISA (pg/L) ] was measured from the centrifuged blood. In routine practice for knee arthroscopy operation under general anesthesia; ECG, pulsoximetry (O2 level measurement with finger probe), blood pressure measurement with cuff, tissue oximetry (NIRS, tissue oxygenation evaluation with probe attached to the relevant skin surface - dorsum of the foot) , patient monitoring was provided and the operation was started by positioning the patients after general anesthesia induction. Blood samples were taken from the foot to be operated on before the tourniquet was inflated and opened. Oxidative stress parameters were analyzed. Within the scope of the study, blood pressure values were recorded in the preoperative period (T0), while the patients were lying flat on the back after general anesthesia (T1), 5 minutes after the tourniquet was placed on the leg to be operated and inflated (T2), 15 minutes later (T3), 30 minutes later (T4), 60 minutes later (T5), before the tourniquet was opened (T6), and after the tourniquet was opened (T7). Tourniquet application was performed as routine, 20 mmHg above the initial blood pressure value, and the tourniquet was lowered in 1 second at the end of the operation. After the tourniquet was removed, d slope time (desaturation descent time), RR time (resaturation ascent time), delta StO2 (difference in tissue oximetry values between before and after anesthesia), hyperemic peak value, hyperemic period time after ischemia were recorded on the tissue oximetry trend monitor (Figure 2). Tourniquet time, duration of operation, duration of anaesthesia, patient's age, weight, height, body mass index, total anaesthetic agent usage, total tramadol administered (24-hour patient-controlled analgesia), and anaesthetic agent doses were recorded. Blood pressure and tissue oximetry values were obtained. Routine awakening and analgesia protocols were applied to the patients. Postoperative pain scale (VAS), operated and non-operated knee algometer values were measured at 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after awakening. Demographic outcomes, anaesthetic agent amounts, pain scores, HIF-1 alpha, and DAF measurements were analysed.
- Keywords
- Hypoxia-inducible factor alfa, tourniquet pain, anesthesia, ischemia, postoperative pain
- Medical subject headings
- Pain, Postoperative, Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the relation between somatic oximeter values and oxidative stress parameters.
To observe the correlation between INVOS™ 5100C Cerebral/Somatic Oximeter measurements(rSO2) (% value) and oxidative stress parameters [ Human hypoxia-inducible factor 1α(HIF-1α) ELISA kit (pg/L), Human decay-accelerating factor(DAF/CD55)ELISA (pg/L) ] measurements after tourniquet inflation and before tourniquet deflation.
Measured: 1 day
Secondary outcomes (1)
The effect of anesthetic agents on oxidative stress parameters.
To investigate the correlation between deslurane (ml), sevoflurane (ml), penthotal(mg), and propofol(mg) usage (ml) to tourniquet-related oxidative stress parameters [Human hypoxia-inducible factor 1α(HIF-1α) ELISA kit (pg/L), Human decay-accelerating factor(DAF/CD55)ELISA (pg/L) ]
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourniquet 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İlknur S YORULMAZ, Assoc. Prof., Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942650
- Sponsor's protocol ID
- 2019/02
- Other IDs
- Duzce University
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prolonged ischemıa and Anesthetic Agents on oxıdatıve Stress Parameters, postoperatıve Pain, and Postoperative Analgesia Requirement
- ClinicalTrials.gov ID
- NCT06942650
- Acronym / sponsor ID
- 2019/02
- Keywords
- Hypoxia-inducible factor alfa, tourniquet pain, anesthesia, ischemia, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 24 Apr 2025 (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 goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced oxidative damage in adults undergoing orthopedic knee arthroscopy surgery.The goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced oxidative damage in adults undergoing orthopedic knee arthroscopy surgery.
The main question it aims to answer is:
Does anesthetic agents used will affect tourniquet-related oxidative stress and postoperative pain ?
Detailed description
Approval was received from Duzce University Clinical Research Ethics Committee(Decision no: 2019/02). Düzce University Among the patients who applied to the Orthopaedics Clinic of Düzce University Medical Faculty, Research and Application Hospital's Orthopaedics Clinic, and planned a knee arthroscopy operation, 60 patients with ASA I-II status who accepted participation and signed the informed consent were included in the study after receiving general anaesthesia. 1 patient was excluded from the study in the analysis part. The results of a total of 59 patients were analysed.
Patients underwent routine anaesthetic examination during preoperative preparation. Informed consent was obtained from all patients. All patients were pressurised at a 90-degree angle to the knee with an algometer (J Tech Commender Echo Algometer, USA), and the average of three measurements was taken. The pressure was displayed in grams (gr) on the digital screen on the front of the devices. The first pressure value at which the patient felt pain was recorded in gr. Measurements were made at three levels (lower, middle, upper) 3-4 cm from the incision site. Measurements around the incision site
Patients were prepared for the operation according to the timing and conditions planned by the relevant clinic, and no preoperative or operative interventions were made regarding the method of operation or anesthesia. The oxidative load (HIF and DAF-16) [ Human hypoxia-inducible factor 1α(HIF-1α) ELISA kit (pg/L), Human decay-accelerating factor(DAF/CD55)ELISA (pg/L) ] was measured from the centrifuged blood. In routine practice for knee arthroscopy operation under general anesthesia; ECG, pulsoximetry (O2 level measurement with finger probe), blood pressure measurement with cuff, tissue oximetry (NIRS, tissue oxygenation evaluation with probe attached to the relevant skin surface - dorsum of the foot) , patient monitoring was provided and the operation was started by positioning the patients after general anesthesia induction. Blood samples were taken from the foot to be operated on before the tourniquet was inflated and opened. Oxidative stress parameters were analyzed. Within the scope of the study, blood pressure values were recorded in the preoperative period (T0), while the patients were lying flat on the back after general anesthesia (T1), 5 minutes after the tourniquet was placed on the leg to be operated and inflated (T2), 15 minutes later (T3), 30 minutes later (T4), 60 minutes later (T5), before the tourniquet was opened (T6), and after the tourniquet was opened (T7). Tourniquet application was performed as routine, 20 mmHg above the initial blood pressure value, and the tourniquet was lowered in 1 second at the end of the operation. After the tourniquet was removed, d slope time (desaturation descent time), RR time (resaturation ascent time), delta StO2 (difference in tissue oximetry values between before and after anesthesia), hyperemic peak value, hyperemic period time after ischemia were recorded on the tissue oximetry trend monitor (Figure 2). Tourniquet time, duration of operation, duration of anaesthesia, patient's age, weight, height, body mass index, total anaesthetic agent usage, total tramadol administered (24-hour patient-controlled analgesia), and anaesthetic agent doses were recorded. Blood pressure and tissue oximetry values were obtained. Routine awakening and analgesia protocols were applied to the patients. Postoperative pain scale (VAS), operated and non-operated knee algometer values were measured at 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after awakening. Demographic outcomes, anaesthetic agent amounts, pain scores, HIF-1 alpha, and DAF measurements were analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty patients aged 18-80, with ASA I-II status, who underwent knee arthroscopy were included in the study. A voluntary consent form was obtained all th e patients.
Key inclusion criteria (3 listed)
- Patients aged 18-80 years,
- (American society of Anesthesiologist) ASA I-II status,
- undergoing knee arthroscopy.
Key exclusion criteria (9 listed)
- Diabetes mellitus,
- advanced chronic obstructive pulmonary disease,
- liver failure,
- renal failure,
- history of previous bypass,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To observe the relation between somatic oximeter values and oxidative stress parameters.
Time frame: 1 day
To observe the correlation between INVOS™ 5100C Cerebral/Somatic Oximeter measurements(rSO2) (% value) and oxidative stress parameters [ Human hypoxia-inducible factor 1α(HIF-1α) ELISA kit (pg/L), Human decay-accelerating factor(DAF/CD55)ELISA (pg/L) ] measurements after tourniquet inflation and before tourniquet deflation.
1 secondary outcome
The effect of anesthetic agents on oxidative stress parameters.
Time frame: 1 day
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 24 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction
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A Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery
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Total Knee Arthroplasty for Gonarthrosis
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.
İlknur S YORULMAZ, Assoc. Prof. principal investigator
Duzce 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 Tourniquet Pain and Ischemia-reperfusion, run by Duzce 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 9 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 24 Apr 2025. 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?
To observe the relation between somatic oximeter values and oxidative stress parameters. (time frame: 1 day). 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 24 Apr 2025.