Postoperative Pain ManagementNCT06758245
Comparative Efficacy of Sciatic and Femoral Blocks in Ankle Surgery
A study testing femoral and anterior sciatic nerve block and femoral and popliteal sciatic nerve block in people with Postoperative Pain Management and Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block vs Femoral and Anterior Sciatic Block in Ankle Surgery Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management, Postoperative Pain, Analgesia
- What is being tested?
- femoral and anterior sciatic nerve block and femoral and popliteal sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Nov 2023to 1 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- American Society of Anesthesiologists physical statusⅠ-II
Who cannot join
- Pregnant
- Neuromuscular disease
- Peripheral neuropathy
- Coagulation disorders
- Allergy to local anesthetics
- Infection at the site where the nerve block will be applied
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gaziosmanpasa Training and Research Hospital, Istanbul, 34000
Istanbul, Gaziosmanpasa, 34255
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block Application With Femoral and Anterior Sciatic Block Application in Ankle Surgery
Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block vs Femoral and Anterior Sciatic Block in Ankle Surgery
Read the detailed description
The sciatic nerve, which arises from the sacral plexus, is the largest nerve in the body. It originates in the posterior region of the thigh in the lumbosacral area and is formed from the anterior branches of spinal nerves from L4 to S3 within the pelvis. It exits the pelvis through the greater sciatic foramen directly below the piriformis and then progresses towards the posterior compartment of the thigh, where it usually divides into the common peroneal nerve and the tibial nerve at the upper corner of the popliteal fossa. Sciatic nerve blocks provide both analgesia and anesthesia in surgeries below the knee, knee surgeries involving the posterior compartment, and foot and ankle surgeries. They can be used alone or in combination with an ipsilateral lumbar plexus block or femoral nerve block to provide surgical anesthesia or analgesia for the entire lower extremity.
Various approaches have been described to perform sciatic nerve block, including anterior and popliteal approaches. The anterior approach to the sciatic nerve can be performed as easily and successfully under ultrasound guidance as the popliteal approach. The anterior approach is advantageous when combined with a femoral nerve block, as it is performed with the patient in the supine position. Due to ease of application and high success rates, peripheral blocks have begun to be incorporated into anesthesia and postoperative analgesia strategies in ankle surgeries. The use of ultrasonography plays a crucial role in increasing the success rate of the block and reducing potential complications.
- Being tested
- femoral and anterior sciatic nerve block, femoral and popliteal sciatic nerve block
- Keywords
- nerve blocks, ankle surgery, postoperative pain, sciatic block, femoral block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral and anterior sciatic nerve blockProcedure or surgery
First, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament. After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz. Using an in-plane technique, the block needle was advanced. Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test.
femoral and popliteal sciatic nerve blockProcedure or surgery
The ultrasound probe is placed transversely at the popliteal crease. The first structure seen is the popliteal artery. Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure. After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease. The needle is advanced using an in-plane technique. After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test.
| Study group | Role | What they receive |
|---|---|---|
| Femoral-Anterior sciatic block group | Active comparator | First, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament. After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz. Using an in-plane technique, the block needle was advanced. Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test. Receives: Procedure: femoral and anterior sciatic nerve block |
| Femoral-popliteal sciatic block group | Active comparator | First, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.The ultrasound probe is placed transversely at the popliteal crease. The first structure seen is the popliteal artery. Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure. After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease. The needle is advanced using an in-plane technique. After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test. Receives: Procedure: femoral and popliteal sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale values
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
Measured: at 1st, 4th,8th 12th ,24th and 48th hours after the surgery
Secondary outcomes (1)
Total amount of opioid requirements
The total tramadol use of the patients in 48 hours will be recorded.
Measured: within 48 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start24 Nov 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital
- Investigators
- Döndü GENÇ MORALAR, MD, Principal investigator, GAZİOSMANPAŞA RESEARCH AND TRAİNİNG HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758245
- Sponsor's protocol ID
- GAZİOSMANPASATREHTAa
- Status last verified
- Aug 2025
- First submitted
- 26 Dec 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Olofsson M, Nguyen A, Rossel JB, Albrecht E. Duration of analgesia after forefoot surgery compared between an ankle and a sciatic nerve block at the popliteal crease: A randomised controlled single-blinded trial. Eur J Anaesthesiol. 2024 Jan 1;41(1):55-60. doi: 10.1097/EJA.0000000000001929. Epub 2023 Nov 16.
PubMed 37972929
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block Application With Femoral and Anterior Sciatic Block Application in Ankle Surgery
- ClinicalTrials.gov ID
- NCT06758245
- Acronym / sponsor ID
- GAZİOSMANPASATREHTAa
- Keywords
- nerve blocks, ankle surgery, postoperative pain, sciatic block, femoral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 3 Jan 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.
Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block vs Femoral and Anterior Sciatic Block in Ankle Surgery
Detailed description
The sciatic nerve, which arises from the sacral plexus, is the largest nerve in the body. It originates in the posterior region of the thigh in the lumbosacral area and is formed from the anterior branches of spinal nerves from L4 to S3 within the pelvis. It exits the pelvis through the greater sciatic foramen directly below the piriformis and then progresses towards the posterior compartment of the thigh, where it usually divides into the common peroneal nerve and the tibial nerve at the upper corner of the popliteal fossa. Sciatic nerve blocks provide both analgesia and anesthesia in surgeries below the knee, knee surgeries involving the posterior compartment, and foot and ankle surgeries. They can be used alone or in combination with an ipsilateral lumbar plexus block or femoral nerve block to provide surgical anesthesia or analgesia for the entire lower extremity.
Various approaches have been described to perform sciatic nerve block, including anterior and popliteal approaches. The anterior approach to the sciatic nerve can be performed as easily and successfully under ultrasound guidance as the popliteal approach. The anterior approach is advantageous when combined with a femoral nerve block, as it is performed with the patient in the supine position. Due to ease of application and high success rates, peripheral blocks have begun to be incorporated into anesthesia and postoperative analgesia strategies in ankle surgeries. The use of ultrasonography plays a crucial role in increasing the success rate of the block and reducing potential complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral-Anterior sciatic block group | Active comparator | Procedure: femoral and anterior sciatic nerve blockFirst, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament. After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz. Using an in-plane technique, the block needle was advanced. Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test. |
| Femoral-popliteal sciatic block group | Active comparator | Procedure: femoral and popliteal sciatic nerve blockFirst, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.The ultrasound probe is placed transversely at the popliteal crease. The first structure seen is the popliteal artery. Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure. After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease. The needle is advanced using an in-plane technique. After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years of age
- American Society of Anesthesiologists physical statusⅠ-II
Key exclusion criteria (6 listed)
- Pregnant
- Neuromuscular disease
- Peripheral neuropathy
- Coagulation disorders
- Allergy to local anesthetics
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 |
|---|---|---|
| femoral and anterior sciatic nerve blockFirst, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament. After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz. Using an in-plane technique, the block needle was advanced. Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test. | Procedure or surgery | Femoral-Anterior sciatic block group |
| femoral and popliteal sciatic nerve blockThe ultrasound probe is placed transversely at the popliteal crease. The first structure seen is the popliteal artery. Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure. After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease. The needle is advanced using an in-plane technique. After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test. | Procedure or surgery | Femoral-popliteal sciatic block group |
Primary outcome
Visual Analogue Scale values
Time frame: at 1st, 4th,8th 12th ,24th and 48th hours after the surgery
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
1 secondary outcome
Total amount of opioid requirements
Time frame: within 48 hours after the surgery
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 28 Aug 2025.
- Background: PubMed 37972929Olofsson M, Nguyen A, Rossel JB, Albrecht E. Duration of analgesia after forefoot surgery compared between an ankle and a sciatic nerve block at the popliteal crease: A randomised controlled single-blinded trial. Eur J Anaesthesiol. 2024 Jan 1;41(1):55-60. doi: 10.1097/EJA.0000000000001929. Epub 2023 Nov 16.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Conditioned Open Label Placebo for Postoperative Pain Management
Pain, Postoperative
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.
Döndü GENÇ MORALAR, MD principal investigator
GAZİOSMANPAŞA RESEARCH AND TRAİNİNG HOSPİTAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femoral and anterior sciatic nerve block and femoral and popliteal sciatic nerve block in people with Postoperative Pain Management and Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital at 2 sites 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual Analogue Scale values (time frame: at 1st, 4th,8th 12th ,24th and 48th hours after the surgery). 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 NCT06758245, which also lists 1 linked publication.
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 28 Aug 2025.