Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle SurgeriesPhase 4NCT06744010
Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries
A Phase 4 study testing Sub sartorial canal block and popliteal block in ankle surgeries and femoral block and popliteal block in ankle surgeries in people with Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Ankle surgeries are severely painful. A sciatic nerve block is typically not enough to cover the pain sources (Delbos et al., 2019). It can be speculated that approaching the saphenous nerve in the subsartorial compartment distal to the point where it pierces the vastoadductor membrane but proximal to the point where… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries
- What is being tested?
- Sub sartorial canal block and popliteal block in ankle surgeries and femoral block and popliteal block in ankle surgeries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2024to 5 Nov 2024
- Phase
- Phase 4
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult patients who will be scheduled to undergo surgery on medial side of the ankle, or both sides of the ankle (Achilles tendon surgery, the removal of an implanted device on the medial side, or ankle arthroscopy) under peripheral nerve blocks (PNBs).
- 2. Patients have an American Society of Anesthesiologists Physical status of I to II.
- 3. Age 19 to 65 years.
Who cannot join
- 1. An inability of patient to cooperate. 2. A history of alcohol or drug abuse. 3. Those with rheumatoid arthritis, coagulation disorders, peripheral neuropathy.
- 4. Known allergies to local anesthetics. 5. Recent use of opioids, corticosteroids, or any other analgesics. 6. If a patient complained of incomplete block before the end of surgery, we will exclude the patient from the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Ankle surgeries are severely painful. A sciatic nerve block is typically not enough to cover the pain sources (Delbos et al., 2019).
It can be speculated that approaching the saphenous nerve in the subsartorial compartment distal to the point where it pierces the vastoadductor membrane but proximal to the point where it penetrates the crural fascia and becomes subcutaneous would selectively target the saphenous nerve without any decrease of quadriceps strength (Jensen et al., 2024).
Read more
Previous study showed that femoral nerve block (FNB) provides good surgical anesthesia and good postoperative pain control for patients with ankle conditions (Lee et al., 2014). However, FNB leads to femoral quadriceps muscle weakness (Jaeger et al., 2013).
Consequently, quadriceps weakness results in functional impairment and it is associated with an increased risk of postoperative falls (Johnson et al., 2013).
Thus far, attempts to reduce quadriceps involvement after FNB without compromising analgesia have not been successful (Li et al., 2019).
Partially because of the increase in the use of ultrasound guidance, a more targeted approach that only blocks sensory fibers of the femoral nerve that supply the operative site has been attempted; thus, the feasibility of sub sartorial canal block has been studied (Kopp et al., 2017).
In recent years, sub sartorial canal block has been successfully used for postoperative pain control after knee surgery (Lavand'homme et al., 2022).
However, no randomized, control study has compared sub sartorial canal block to femoral nerve block for ankle surgeries. We hypothesized that compared to femoral nerve block, sub sartorial canal block would demonstrate noninferior pain scores during surgery and until 48 hours postoperatively and cause less weakness in the quadriceps.
Read the detailed description
Sample size was calculated using Power Analysis and Sample Size Software (PASS 2020) "NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass". Based on a previously published study (Lavand'homme et al., 2022) and (Joe et al., 2016); the VAS pain scores of the adductor canal block group were not inferior during and after the operation compared to those of the FNB group. At 30 minutes and 2 hours after anesthesia, patients who received an adductor canal block had significantly higher average dynamometer readings than those who received a FNB (34.2±20.4 and 30.4±23.7 vs 1.7±3.7 and 2.3±7.4, respectively), and the results were similar at 24 and 48 hours after anesthesia. Based on this, a minimal total hypothesized sample size of 60 eligible patients will be needed taking into consideration 95% level of confidence, an effect size of 1/100 and 5% margin of error using two-sided proportional Z- test. Sample size will be increased 20% for possible dropout rate, so 72 patients will be enrolled in the study (36 in each group).
- Randomization: It will be based on a computer-generated block randomization list (4 numbers per block) in a 1:1 ratio. All patients underwent sub sartorial canal block + popliteal block, or femoral block + popliteal block according to a randomized assignment . the randomization sequence was kept hidden in sealed opaque envelopes. After recruitment and admittance to blocking room , the authors unwrapped the envelopes . the allocations of the group were blinded to assessors , data collectors with an expert anesthesiologist doing the block (single blinded).
- Study tools:
- After approval of study protocol, patients will be enrolled into the study according to inclusion and exclusion criteria.
- A total of 72 patients will be categorized into 2 groups:
- Group A "sub sartorial canal block + popliteal block".
- Group B "femoral block + popliteal block".
- Anesthesia and postoperative analgesia:
- All patients will be anesthetized with PNBs for surgery.
- PNBs will be performed in a block room at least 30minute preoperatively.
- All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz).
- All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques.
- A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve.
- The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%.
- The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
- For the ultrasound-guided sub sartorial compartment block of the saphenous nerve, the patient will be placed in the supine position with external rotation of the thigh and slight flexion of the knee. A 15 MHz linear ultrasound probe (PX, FUJIFILM SonoSite, Bothell, Washington, USA) will be placed in the transverse plane across the sartorius muscle approximately at the base of the patella. The sartorius muscle will be followed proximally and distally in order to visualize the segment of the sub sartorial compartment between the two points where the saphenous nerve intersected the tendons of the adductor magnus and semimembranosus muscles, respectively. The saphenous nerve will be visualized in the proximal half of this segment of the subsartorial compartment - just distal to the intersection of the saphenous nerve and the tendon of the adductor magnus muscle. At this level there is a well-defined subsartorial compartment between the sartorius muscle tendon and the so-called 'subsartorial fat pad' that is compliant for injection. The needle will be inserted ultrasound-guided in-plane from anterior to posterior and advanced in order to place the needle tip adjacent to the saphenous nerve and inject perineurally.
- For popliteal sciatic nerve block, the patient will be lain laterally on the opposite side of the limb which has to be blocked. The limb to be blocked will be flexed partially at hip and knee joint. Using a high-frequency linear probe, a scan of popliteal fossa will be conducted to identify separate tibial and common peroneal nerves lying superficially and posteriorly to popliteal artery. Movement of the probe proximally brings tibial and common peroneal nerves together to form the sciatic nerve at a variable point, above the popliteal crease. At this level, via out-of plane technique, using 21 gauge insulated needle, 20 ml of 0.5% ropivacaine will be deposited after negative aspiration and real-time spread of local anesthetic will be visualized in sub paraneural space around the sciatic nerve.
- For the femoral nerve block, the femoral nerve will be identified lateral to the femoral artery at the inguinal crease in the transverse section. The study medication will be injected anterior and posterior to the nerve.
- The actual or estimated needle insertion sites will be covered with a dressing bandage in all patients to blind those assessing the outcome of the procedure to the treatment.
- Intravenous ketorolac tromethamine (30mg, maximum dose 90mg/d) will be given as a rescue analgesic during the first 48 hours postoperatively when a patient reported a visual analog scale (VAS) score of ≥5 or if the patient requested pain relief.
- All the patients will receive 0.03 mg/kg of intra-venous midazolam and oxygen will be supplied by face mask throughout the procedure.
- Surgery will be started after adequate sensory and motor blockade will be achieved.
- In patients with failure to achieve adequate surgical anesthesia after 20 minutes of administration of block, it will be considered as a block failure and converted to general anesthesia.
- Being tested
- Sub sartorial canal block and popliteal block in ankle surgeries, femoral block and popliteal block in ankle surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub sartorial canal block and popliteal block in ankle surgeriesProcedure or surgery
All patients will be anesthetized with PNBs for surgery.
- PNBs will be performed in a block room at least 30minute preoperatively.
- All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz).
- All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques.
- A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve.
- The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%.
- The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
femoral block and popliteal block in ankle surgeriesProcedure or surgery
- All patients will be anesthetized with PNBs for surgery.
- PNBs will be performed in a block room at least 30minute preoperatively.
- All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz).
- All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques.
- A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve.
- The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%.
- The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | sub sartorial canal block + popliteal block Receives: Procedure: Sub sartorial canal block and popliteal block in ankle surgeries |
| Group B | Experimental | femoral block + popliteal block Receives: Procedure: femoral block and popliteal block in ankle surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
Visual analogue score at 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively
Measured: 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively
Secondary outcomes (9)
• Quadriceps muscle power.
- Quadriceps muscle power.
Measured: In the first 48 hours after surgery.
Number of patients requiring analgesic rescue in the first 48 hours after surgery.
Number of patients requiring analgesic rescue in the first 48 hours after surgery.
Measured: In the first 48 hours after surgery.
Total opioid consumption.
Total opioid consumption.
Measured: In the first 48 hours after surgery.
Duration of the procedure
Duration of the procedure
Measured: In the first 48 hours
Time to full anesthesia
Time to full anesthesia
Measured: 20 to 30 minutes before surgery
Operative time
Operative time
Measured: 6 hours
Recovery time
Recovery time
Measured: 48 hours after surgery
Patient satisfaction questionnaire
Patient satisfaction
Measured: In the first 48 hours after surgery
Incidence of complications
Incidence of complications
Measured: In the first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start5 Jun 2024
- Primary completion5 Sep 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle SurgeriesStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Gaber Ragab, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744010
- Sponsor's protocol ID
- M 739
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.
PubMed 31663286Kopp SL, Borglum J, Buvanendran A, Horlocker TT, Ilfeld BM, Memtsoudis SG, Neal JM, Rawal N, Wegener JT. Anesthesia and Analgesia Practice Pathway Options for Total Knee Arthroplasty: An Evidence-Based Review by the American and European Societies of Regional Anesthesia and Pain Medicine. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):683-697. doi: 10.1097/AAP.0000000000000673.
PubMed 29053504Joe HB, Choo HS, Yoon JS, Oh SE, Cho JH, Park YU. Adductor canal block versus femoral nerve block combined with sciatic nerve block as an anesthetic technique for hindfoot and ankle surgery: A prospective, randomized noninferiority trial. Medicine (Baltimore). 2016 Dec;95(52):e5758. doi: 10.1097/MD.0000000000005758.
PubMed 28033291Jensen AE, Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Vaeggemose M, Bendtsen TF. Distal subsartorial compartment block of the saphenous nerve - A dissection study and a patient case series. J Clin Anesth. 2024 Feb;92:111315. doi: 10.1016/j.jclinane.2023.111315. Epub 2023 Nov 3.
PubMed 37926063Delbos A, Philippe M, Clement C, Olivier R, Coppens S. Ultrasound-guided ankle block. History revisited. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):79-93. doi: 10.1016/j.bpa.2019.05.002. Epub 2019 May 7.
PubMed 31272656
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries
- ClinicalTrials.gov ID
- NCT06744010
- Acronym / sponsor ID
- M 739
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 20 Dec 2024 (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.
Ankle surgeries are severely painful. A sciatic nerve block is typically not enough to cover the pain sources (Delbos et al., 2019).
It can be speculated that approaching the saphenous nerve in the subsartorial compartment distal to the point where it pierces the vastoadductor membrane but proximal to the point where it penetrates the crural fascia and becomes subcutaneous would selectively target the saphenous nerve without any decrease of quadriceps strength (Jensen et al., 2024).
Previous study showed that femoral nerve block (FNB) provides good surgical anesthesia and good postoperative pain control for patients with ankle conditions (Lee et al., 2014). However, FNB leads to femoral quadriceps muscle weakness (Jaeger et al., 2013).
Consequently, quadriceps weakness results in functional impairment and it is associated with an increased risk of postoperative falls (Johnson et al., 2013).
Thus far, attempts to reduce quadriceps involvement after FNB without compromising analgesia have not been successful (Li et al., 2019).
Partially because of the increase in the use of ultrasound guidance, a more targeted approach that only blocks sensory fibers of the femoral nerve that supply the operative site has been attempted; thus, the feasibility of sub sartorial canal block has been studied (Kopp et al., 2017).
In recent years, sub sartorial canal block has been successfully used for postoperative pain control after knee surgery (Lavand'homme et al., 2022).
However, no randomized, control study has compared sub sartorial canal block to femoral nerve block for ankle surgeries. We hypothesized that compared to femoral nerve block, sub sartorial canal block would demonstrate noninferior pain scores during surgery and until 48 hours postoperatively and cause less weakness in the quadriceps.
Detailed description
Sample size was calculated using Power Analysis and Sample Size Software (PASS 2020) "NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass". Based on a previously published study (Lavand'homme et al., 2022) and (Joe et al., 2016); the VAS pain scores of the adductor canal block group were not inferior during and after the operation compared to those of the FNB group. At 30 minutes and 2 hours after anesthesia, patients who received an adductor canal block had significantly higher average dynamometer readings than those who received a FNB (34.2±20.4 and 30.4±23.7 vs 1.7±3.7 and 2.3±7.4, respectively), and the results were similar at 24 and 48 hours after anesthesia. Based on this, a minimal total hypothesized sample size of 60 eligible patients will be needed taking into consideration 95% level of confidence, an effect size of 1/100 and 5% margin of error using two-sided proportional Z- test. Sample size will be increased 20% for possible dropout rate, so 72 patients will be enrolled in the study (36 in each group).
- Randomization: It will be based on a computer-generated block randomization list (4 numbers per block) in a 1:1 ratio. All patients underwent sub sartorial canal block + popliteal block, or femoral block + popliteal block according to a randomized assignment . the randomization sequence was kept hidden in sealed opaque envelopes. After recruitment and admittance to blocking room , the authors unwrapped the envelopes . the allocations of the group were blinded to assessors , data collectors with an expert anesthesiologist doing the block (single blinded).
- Study tools:
- After approval of study protocol, patients will be enrolled into the study according to inclusion and exclusion criteria.
- A total of 72 patients will be categorized into 2 groups:
- Group A "sub sartorial canal block + popliteal block".
- Group B "femoral block + popliteal block".
- Anesthesia and postoperative analgesia:
- All patients will be anesthetized with PNBs for surgery.
- PNBs will be performed in a block room at least 30minute preoperatively.
- All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz).
- All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques.
- A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve.
- The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%.
- The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
- For the ultrasound-guided sub sartorial compartment block of the saphenous nerve, the patient will be placed in the supine position with external rotation of the thigh and slight flexion of the knee. A 15 MHz linear ultrasound probe (PX, FUJIFILM SonoSite, Bothell, Washington, USA) will be placed in the transverse plane across the sartorius muscle approximately at the base of the patella. The sartorius muscle will be followed proximally and distally in order to visualize the segment of the sub sartorial compartment between the two points where the saphenous nerve intersected the tendons of the adductor magnus and semimembranosus muscles, respectively. The saphenous nerve will be visualized in the proximal half of this segment of the subsartorial compartment - just distal to the intersection of the saphenous nerve and the tendon of the adductor magnus muscle. At this level there is a well-defined subsartorial compartment between the sartorius muscle tendon and the so-called 'subsartorial fat pad' that is compliant for injection. The needle will be inserted ultrasound-guided in-plane from anterior to posterior and advanced in order to place the needle tip adjacent to the saphenous nerve and inject perineurally.
- For popliteal sciatic nerve block, the patient will be lain laterally on the opposite side of the limb which has to be blocked. The limb to be blocked will be flexed partially at hip and knee joint. Using a high-frequency linear probe, a scan of popliteal fossa will be conducted to identify separate tibial and common peroneal nerves lying superficially and posteriorly to popliteal artery. Movement of the probe proximally brings tibial and common peroneal nerves together to form the sciatic nerve at a variable point, above the popliteal crease. At this level, via out-of plane technique, using 21 gauge insulated needle, 20 ml of 0.5% ropivacaine will be deposited after negative aspiration and real-time spread of local anesthetic will be visualized in sub paraneural space around the sciatic nerve.
- For the femoral nerve block, the femoral nerve will be identified lateral to the femoral artery at the inguinal crease in the transverse section. The study medication will be injected anterior and posterior to the nerve.
- The actual or estimated needle insertion sites will be covered with a dressing bandage in all patients to blind those assessing the outcome of the procedure to the treatment.
- Intravenous ketorolac tromethamine (30mg, maximum dose 90mg/d) will be given as a rescue analgesic during the first 48 hours postoperatively when a patient reported a visual analog scale (VAS) score of ≥5 or if the patient requested pain relief.
- All the patients will receive 0.03 mg/kg of intra-venous midazolam and oxygen will be supplied by face mask throughout the procedure.
- Surgery will be started after adequate sensory and motor blockade will be achieved.
- In patients with failure to achieve adequate surgical anesthesia after 20 minutes of administration of block, it will be considered as a block failure and converted to general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Sub sartorial canal block and popliteal block in ankle surgeriessub sartorial canal block + popliteal block |
| Group B | Experimental | Procedure: femoral block and popliteal block in ankle surgeriesfemoral block + popliteal block |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Adult patients who will be scheduled to undergo surgery on medial side of the ankle, or both sides of the ankle (Achilles tendon surgery, the removal of an implanted device on the medial side, or ankle arthroscopy) under peripheral nerve blocks (PNBs).
- 2. Patients have an American Society of Anesthesiologists Physical status of I to II.
- 3. Age 19 to 65 years.
Key exclusion criteria (2 listed)
- 1. An inability of patient to cooperate. 2. A history of alcohol or drug abuse. 3. Those with rheumatoid arthritis, coagulation disorders, peripheral neuropathy.
- 4. Known allergies to local anesthetics. 5. Recent use of opioids, corticosteroids, or any other analgesics. 6. If a patient complained of incomplete block before the end of surgery, we will exclude the patient from the analysis.
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 |
|---|---|---|
| Sub sartorial canal block and popliteal block in ankle surgeriesAll patients will be anesthetized with PNBs for surgery. * PNBs will be performed in a block room at least 30minute preoperatively. * All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz). * All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques. * A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve. * The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%. * The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4. | Procedure or surgery | Group A |
| femoral block and popliteal block in ankle surgeries* All patients will be anesthetized with PNBs for surgery. * PNBs will be performed in a block room at least 30minute preoperatively. * All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz). * All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques. * A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve. * The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%. * The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4. | Procedure or surgery | Group B |
Primary outcome
Visual analogue score
Time frame: 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively
Visual analogue score at 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively
9 secondary outcomes
• Quadriceps muscle power.
Time frame: In the first 48 hours after surgery.
Number of patients requiring analgesic rescue in the first 48 hours after surgery.
Time frame: In the first 48 hours after surgery.
Total opioid consumption.
Time frame: In the first 48 hours after surgery.
Duration of the procedure
Time frame: In the first 48 hours
Time to full anesthesia
Time frame: 20 to 30 minutes before surgery
Operative time
Time frame: 6 hours
Recovery time
Time frame: 48 hours after surgery
Patient satisfaction questionnaire
Time frame: In the first 48 hours after surgery
Incidence of complications
Time frame: In the first 48 hours after 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 20 Dec 2024.
- Results publication: PubMed 31663286Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.
- Results publication: PubMed 29053504Kopp SL, Borglum J, Buvanendran A, Horlocker TT, Ilfeld BM, Memtsoudis SG, Neal JM, Rawal N, Wegener JT. Anesthesia and Analgesia Practice Pathway Options for Total Knee Arthroplasty: An Evidence-Based Review by the American and European Societies of Regional Anesthesia and Pain Medicine. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):683-697. doi: 10.1097/AAP.0000000000000673.
- Results publication: PubMed 28033291Joe HB, Choo HS, Yoon JS, Oh SE, Cho JH, Park YU. Adductor canal block versus femoral nerve block combined with sciatic nerve block as an anesthetic technique for hindfoot and ankle surgery: A prospective, randomized noninferiority trial. Medicine (Baltimore). 2016 Dec;95(52):e5758. doi: 10.1097/MD.0000000000005758.
- Results publication: PubMed 37926063Jensen AE, Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Vaeggemose M, Bendtsen TF. Distal subsartorial compartment block of the saphenous nerve - A dissection study and a patient case series. J Clin Anesth. 2024 Feb;92:111315. doi: 10.1016/j.jclinane.2023.111315. Epub 2023 Nov 3.
- Results publication: PubMed 31272656Delbos A, Philippe M, Clement C, Olivier R, Coppens S. Ultrasound-guided ankle block. History revisited. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):79-93. doi: 10.1016/j.bpa.2019.05.002. Epub 2019 May 7.
- Individual participant dataSharing planned: Undecided
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 Phase 4 study testing Sub sartorial canal block and popliteal block in ankle surgeries and femoral block and popliteal block in ankle surgeries in people with Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries, run by Fayoum University Hospital at 1 site in Egypt.
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 2 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 20 Dec 2024. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 score (time frame: 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively). 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 NCT06744010, which also lists 5 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 20 Dec 2024.