Popliteal Sciatic Nerve BlockNCT05960422
Popliteal Sciatic Nerve Block and Adductor Canal Block
A study testing Popliteal Sciatic Nerve Block and Adductor canal block in people with Popliteal Sciatic Nerve Block and Adductor Canal Block, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine the effect of adding adductor canal block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative sedation need, tourniquet pain, return time of motor block, and postoperative pain in patients undergoing hallux valgus correction surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Popliteal Sciatic Nerve Block, Adductor Canal Block
- What is being tested?
- Popliteal Sciatic Nerve Block and Adductor canal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 10 Feb 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80
- American Society of Anesthesiologists ASA I-III
Who cannot join
- Patients with coagulopathy
- Patient with wounds or infections in the region
- Patient with allergies to local anesthetic drugs
- Patient with significantly impaired peripheral neuropathy and neurogenic disorders affecting the lower extremity
- Patient with peripheral arterial disease
- Patient with mental retardation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Faculty of Medicine Department of Anesthesiology and Reanimation
Istanbul, Kadikoy, 34720
About this study
Official title: Effects of Adding Adductor Canal Block to Popliteal Sciatic Nerve Block in Hallux Valgus Correction Operations
The goal of this observational study is to determine the effect of adding adductor canal block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative sedation need, tourniquet pain, return time of motor block, and postoperative pain in patients undergoing hallux valgus correction surgery. The main question it aims to answer are:
- Does peroperative pain decrease?
- Do patient-surgeon satisfaction increase? The patients were divided into two groups, the Popliteal Sciatic Block (PSB) group, and the Popliteal Sciatic Block + Adductor Canal Block (PSB + ACB) group.
Read the detailed description
Patients were randomly assigned into 2 groups as popliteal sciatic nerve block (Group PSB), popliteal sciatic nerve + adductor canal block (Group PSB + ACB). In this study, 52 patients scheduled for hallux valgus correction operations, in the American Society of Anesthesiologists I-III groups, between the ages of 18-80, were enrolled. Study was planned as a prospective, randomized and controlled trial. All patients were perfomed PSB with 10 ml 0.5% bupivacaine and 10 ml 2% prilocaine in the prone position, using ultrasonography and nerve stimulator. 10 ml of 0.5% bupivacaine and 10 ml of 2% prilocaine were administered to the patients in the ACB + PSB group in the supine position, in addition to PSB. Patients with coagulopathy, infection at the region site of regional blockade, allergy of local anesthetic drugs, peripheral neuropathy and neurogenic disorders affecting the lower extremities, peripheral artery disease, mental retardation and those who did not give consent to study were excluded. All patients were sedated with 1-2 mg midazolam and 50 µg fentanyl. After the blocks were performed , sensory -motor block onset time, surgery-tourniquet time, tourniquet pain, motor block time, pain onset time, first analgesic administration time (NPRS≥4) and analgesic administered were recorded. Anesthesiologists evaluating these data were blinded to group distribution .
- Being tested
- Popliteal Sciatic Nerve Block, Adductor canal block
- Keywords
- Popliteal sciatic block, adductor canal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popliteal Sciatic Nerve BlockProcedure or surgery
Patients undergoing popliteal sciatic block, the side where the procedure would be performed in the prone position was sterilized after appropriate antisepsis. After visualizing the popliteal artery in the popliteal fossa with the probe it was advanced proximally in a horizontal and minimally lateral position to determine the point of separation of the tibial and peroneal nerves from the sciatic nerve. Subcutaneous local anesthesia was applied at this point after the skin, and the stimulator needle was advanced towards the sciatic nerve in an in-plane approach, passing through the skin and subcutaneous tissue, and then the nerve stimulator was opened up to 1 mA. After observing motor movement in the foot, the stimulator was reduced to 0.3-0.5 mA, and after observing motor movements for duration of 0.1 ms, 10 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine were administered to the target tissue
Adductor canal blockProcedure or surgery
Patients in the group undergoing popliteal sciatic block + adductor canal block, with the extremity to be blocked slightly externally rotated, the anterior part of the thigh was prepared with the necessary antiseptic procedures while the patient was in the supine position. Using an ultrasound probe, the femoral artery was visualized by advancing the ultrasound probe distally, and the saphenous nerve was identified just lateral to the femoral artery, beneath the sartorius muscle. At the junction of the sartorius muscle and vastus medialis, 10 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine were applied to the periphery of the saphenous nerve. Subsequently, the patient was turned prone, and a popliteal sciatic block was performed.
| Study group | Role | What they receive |
|---|---|---|
| Popliteal Sciatic Nerve Block | Active comparator | Patients are in the group undergoing popliteal sciatic block Receives: Procedure: Popliteal Sciatic Nerve Block |
| Adductor Canal Block | Active comparator | Patients are in the group undergoing popliteal sciatic block + adductor canal block Receives: Procedure: Adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
The Numeric Pain Rating Scale (NPRS). Between 1-10. The low values mean low pain and a better outcome.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Sep 2021
- Primary completion10 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Sciatic Nerve BlockStudies 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
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi POLAT, Istanbul Medeniyet University
- Investigators
- Ezgi Polat, Principal investigator, İstanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960422
- Sponsor's protocol ID
- EzgiPOLAT
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Adductor Canal Block to Popliteal Sciatic Nerve Block in Hallux Valgus Correction Operations
- ClinicalTrials.gov ID
- NCT05960422
- Acronym / sponsor ID
- EzgiPOLAT
- Keywords
- Popliteal sciatic block, adductor canal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 25 Jul 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.
The goal of this observational study is to determine the effect of adding adductor canal block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative sedation need, tourniquet pain, return time of motor block, and postoperative pain in patients undergoing hallux valgus correction surgery. The main question it aims to answer are:
- Does peroperative pain decrease?
- Do patient-surgeon satisfaction increase? The patients were divided into two groups, the Popliteal Sciatic Block (PSB) group, and the Popliteal Sciatic Block + Adductor Canal Block (PSB + ACB) group.
Detailed description
Patients were randomly assigned into 2 groups as popliteal sciatic nerve block (Group PSB), popliteal sciatic nerve + adductor canal block (Group PSB + ACB). In this study, 52 patients scheduled for hallux valgus correction operations, in the American Society of Anesthesiologists I-III groups, between the ages of 18-80, were enrolled. Study was planned as a prospective, randomized and controlled trial. All patients were perfomed PSB with 10 ml 0.5% bupivacaine and 10 ml 2% prilocaine in the prone position, using ultrasonography and nerve stimulator. 10 ml of 0.5% bupivacaine and 10 ml of 2% prilocaine were administered to the patients in the ACB + PSB group in the supine position, in addition to PSB. Patients with coagulopathy, infection at the region site of regional blockade, allergy of local anesthetic drugs, peripheral neuropathy and neurogenic disorders affecting the lower extremities, peripheral artery disease, mental retardation and those who did not give consent to study were excluded. All patients were sedated with 1-2 mg midazolam and 50 µg fentanyl. After the blocks were performed , sensory -motor block onset time, surgery-tourniquet time, tourniquet pain, motor block time, pain onset time, first analgesic administration time (NPRS≥4) and analgesic administered were recorded. Anesthesiologists evaluating these data were blinded to group distribution .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Popliteal Sciatic Nerve Block | Active comparator | Procedure: Popliteal Sciatic Nerve BlockPatients are in the group undergoing popliteal sciatic block |
| Adductor Canal Block | Active comparator | Procedure: Adductor canal blockPatients are in the group undergoing popliteal sciatic block + adductor canal block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 80
- American Society of Anesthesiologists ASA I-III
Key exclusion criteria (6 listed)
- Patients with coagulopathy
- Patient with wounds or infections in the region
- Patient with allergies to local anesthetic drugs
- Patient with significantly impaired peripheral neuropathy and neurogenic disorders affecting the lower extremity
- Patient with peripheral arterial disease
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 |
|---|---|---|
| Popliteal Sciatic Nerve BlockPatients undergoing popliteal sciatic block, the side where the procedure would be performed in the prone position was sterilized after appropriate antisepsis. After visualizing the popliteal artery in the popliteal fossa with the probe it was advanced proximally in a horizontal and minimally lateral position to determine the point of separation of the tibial and peroneal nerves from the sciatic nerve. Subcutaneous local anesthesia was applied at this point after the skin, and the stimulator needle was advanced towards the sciatic nerve in an in-plane approach, passing through the skin and subcutaneous tissue, and then the nerve stimulator was opened up to 1 mA. After observing motor movement in the foot, the stimulator was reduced to 0.3-0.5 mA, and after observing motor movements for duration of 0.1 ms, 10 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine were administered to the target tissue | Procedure or surgery | Popliteal Sciatic Nerve Block |
| Adductor canal blockPatients in the group undergoing popliteal sciatic block + adductor canal block, with the extremity to be blocked slightly externally rotated, the anterior part of the thigh was prepared with the necessary antiseptic procedures while the patient was in the supine position. Using an ultrasound probe, the femoral artery was visualized by advancing the ultrasound probe distally, and the saphenous nerve was identified just lateral to the femoral artery, beneath the sartorius muscle. At the junction of the sartorius muscle and vastus medialis, 10 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine were applied to the periphery of the saphenous nerve. Subsequently, the patient was turned prone, and a popliteal sciatic block was performed. | Procedure or surgery | Adductor Canal Block |
Primary outcome
Postoperative Pain
Time frame: Postoperative 24 hours
The Numeric Pain Rating Scale (NPRS). Between 1-10. The low values mean low pain and a better outcome.
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 1 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Popliteal Sciatic Nerve Block
RecruitingObservational study
Assessing the Enhanced Precision: The Value of Impedance in Ultrasound-Guided Nerve Blocks (Axillary, Interscalene, Popliteal Sciatic), an Exploratory Prospective Observational Study
Impedance, Axillary Nerve Block
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.
Ezgi Polat principal investigator
İstanbul Medeniyet 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 Popliteal Sciatic Nerve Block and Adductor canal block in people with Popliteal Sciatic Nerve Block and Adductor Canal Block, run by Istanbul Medeniyet 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 2 inclusion and 6 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 1 Aug 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?
Postoperative Pain (time frame: Postoperative 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 1 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.