Lower ExtremityPSSNB-BLNCT07550348
Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block
A study testing Bupivacaine-Lidocaine Combination and Bupivacaine in people with Lower Extremity and Nerve Block, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind clinical trial aims to compare the efficacy of two local anesthetic regimens for ultrasound-guided popliteal sciatic nerve block in adult patients undergoing elective distal lower extremity surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Extremity, Nerve Block, Pain, Postoperative
- What is being tested?
- Bupivacaine-Lidocaine Combination and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III
- Scheduled for elective distal lower extremity surgery (below-knee)
- Body mass index (BMI) between 18 and 35 kg/m²
- Provision of written informed consent
Who cannot join
- Refusal to participate in the study
- Morbid obesity (BMI ≥35 kg/m²)
- Known allergy or hypersensitivity to any local anesthetic agent
- Severe cardiac, hepatic, or renal disease
- Pre-existing neurological deficits or peripheral neuropathy
- Use of anticoagulant therapy
Show all 9Show fewer
- History of prior surgery or significant scar tissue in the popliteal fossa
- Pregnancy
- Chronic opioid use at home
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University
Erzurum
Ahmet Murat Yayik, MD, 00905544259287, ahmetmuratyayik@gmail.com
About this study
Official title: Bupivacaine-Lidocaine Combination Versus Bupivacaine Alone for Ultrasound-Guided Popliteal Sciatic Nerve Block in Elective Lower Extremity Surgery: A Prospective Randomized Double-Blind Trial
This prospective, randomized, double-blind clinical trial aims to compare the efficacy of two local anesthetic regimens for ultrasound-guided popliteal sciatic nerve block in adult patients undergoing elective distal lower extremity surgery.
Eligible participants (ages 18-65, ASA physical status I-III, BMI 18-35 kg/m²) will be randomized into two equal groups of 30. Patients in Group BL will receive a combination of 10 mL 2% lidocaine and 10 mL 0.5% bupivacaine, while patients in Group B will receive 20 mL 0.5% bupivacaine alone, administered via ultrasound-guided popliteal sciatic nerve block prior to surgery.
Read more
The primary outcome is the onset time of sensory and motor blockade. Secondary outcomes include block success rate, duration of sensory and motor block, postoperative opioid consumption, pain scores assessed by the Numeric Rating Scale (NRS) at 2, 4, 8, 12, and 24 hours postoperatively, Quality of Recovery-15 (QoR-15) score, and incidence of rebound pain.
The study is conducted at Ataturk University Research Hospital, Department of Anesthesiology and Reanimation, Erzurum, Turkey.
Read the detailed description
Background and Rationale
Peripheral nerve blocks have become an increasingly preferred technique for both anesthesia and analgesia in distal lower extremity surgery, offering advantages such as reduced opioid consumption, stable intraoperative hemodynamics, lower rates of postoperative nausea and vomiting, and enhanced early mobilization. The popliteal approach to the sciatic nerve provides effective surgical anesthesia for foot, ankle, and distal leg procedures, with high patient satisfaction and a low complication profile. Ultrasound guidance further improves block success rates by enabling direct visualization of perineural anatomical structures.
The choice of local anesthetic plays a critical role in determining block onset time, duration of sensory and motor blockade, and overall analgesic duration. Lidocaine offers rapid onset and short-to-intermediate duration, while bupivacaine provides prolonged sensory and motor blockade, thereby reducing postoperative opioid requirements. The combination of these two agents theoretically enables simultaneous achievement of rapid onset and prolonged analgesia; however, the net effect of this combination on block characteristics remains inconclusive in the current literature.
Study Design
This is a prospective, randomized, double-blind, single-center, two-arm parallel-group clinical trial conducted at Ataturk University Research Hospital, Department of Anesthesiology and Reanimation, Erzurum, Turkey.
Participants
A total of 60 adult patients scheduled for elective distal lower extremity surgery will be enrolled. Inclusion criteria: age 18-65 years, ASA physical status I-III, body mass index (BMI) 18-35 kg/m², and written informed consent. Exclusion criteria include inability to provide informed consent, coagulopathy, sepsis, hepatic or renal insufficiency, known allergy to local anesthetics, prior surgery or significant scar tissue in the popliteal fossa, pregnancy, and chronic opioid use at home.
Randomization and Blinding
Eligible patients will be randomized in a 1:1 ratio using a computer-generated random number list into two groups of 30. Study solutions will be prepared by a dedicated investigator not involved in block performance or outcome assessment. Patients and the outcome assessor will be blinded to group allocation (double-blind). The anesthesiologist performing the block will be aware of the group allocation. Block procedures will be performed by an anesthesiologist with a minimum of two years of experience in ultrasound-guided regional anesthesia who is not involved in patient care.
Intervention
All patients will receive an ultrasound-guided popliteal sciatic nerve block using a total volume of 20 mL local anesthetic solution. Patients will be positioned prone or in lateral decubitus with the operative limb uppermost and the knee in slight flexion. Under aseptic conditions, a high-frequency linear ultrasound probe will be placed transversely over the popliteal fossa to visualize the popliteal artery and the tibial nerve. The probe will be advanced proximally to identify the tibial and common peroneal nerve bifurcation. A 100 mm echogenic block needle will be advanced in-plane from lateral to medial. After confirming circumferential perineural spread of 1-2 mL test injection under ultrasound guidance, the study solution will be incrementally injected with repeated aspiration checks.
Group BL (n=30): 10 mL 2% lidocaine + 10 mL 0.5% bupivacaine (administered sequentially in separate syringes)
Group B (n=30): 20 mL 0.5% bupivacaine (administered in two 10 mL syringes) In cases involving the medial malleolus or medial leg surface, an additional adductor canal block will be performed using 10 mL of the respective study solution.
Intraoperative Management Conscious sedation will be maintained intraoperatively with intravenous dexmedetomidine (loading dose: 0.5-1 µg/kg over 10 minutes; maintenance: 0.2-0.7 µg/kg/hour). Continuous monitoring of heart rate, non-invasive blood pressure, oxygen saturation, and electrocardiography will be performed throughout the procedure.
Postoperative Analgesia Protocol All patients will receive intravenous paracetamol 1000 mg 30 minutes before the end of surgery, repeated every 8 hours postoperatively. Intravenous dexketoprofen 50 mg will be administered intraoperatively and repeated every 12 hours. Rescue analgesia with intravenous tramadol 100 mg will be administered for NRS ≥ 4, with a maximum of 3 doses per day and a minimum interval of 4-6 hours between doses.
Outcome Measures Primary Outcome: The primary outcome is the duration of sensory block. It is defined as the time to return of sensation in the postoperative period, i.e., the time at which the patient first reports regaining sensation in the toes. Sensory function will be assessed at 1, 2, 4, 8, 12, and 24 hours postoperatively. The time of sensory recovery will be confirmed by in-person visit or telephone interview at 24, 48, and 72 hours after block performance.
Secondary Outcomes:
Block onset time: Time elapsed from completion of local anesthetic injection to first achievement of block success criteria.
Block success rate: Proportion of patients achieving a total sensorimotor score ≥12/14 with a sensory score ≥7/8 within 60 minutes of injection.
Adequacy of surgical anesthesia: Completion of surgery without the need for supplemental general anesthesia or local infiltration at the surgical site.
Duration of motor block: Time to return of motor function in the postoperative period, i.e., the time at which the patient is first able to move the toes. Motor function will be assessed at 1, 2, 4, 8, 12, and 24 hours postoperatively.
Duration of analgesia: Time to first reported pain after block performance. Postoperative pain scores: Pain intensity assessed using the Numeric Rating Scale (NRS 0-10) at 1, 2, 4, 8, 12, and 24 hours postoperatively. The highest NRS score will additionally be recorded at 24, 48, and 72 hours.
Quality of recovery: QoR-15 score (0-150; higher scores indicate better recovery) assessed preoperatively (baseline) and at 24 hours postoperatively.
Incidence of rebound pain: Defined as NRS ≥7 within 24 hours after resolution of the sensory block.
Neurological complications: Presence of paresthesia, numbness, or motor deficit in the blocked extremity, assessed by telephone interview or outpatient clinic visit on postoperative day 7.
Block Assessment
Sensory block will be assessed using the pinprick test across four nerve territories: tibial (plantar aspect of the foot), deep peroneal (first web space), superficial peroneal (dorsum of the foot), and sural (lateral border of the fifth metatarsal). Each territory will be scored from 0 to 2 (0 = normal sensation; 1 = analgesia, i.e., the patient perceives touch but not pinprick; 2 = anesthesia, i.e., the patient perceives neither touch nor pinprick), giving a maximum score of 8.
Motor block will be evaluated across three nerve territories: tibial (ankle plantar flexion), deep peroneal (ankle dorsiflexion), and superficial peroneal (foot eversion). Each territory will be scored from 0 to 2 (0 = normal; 1 = paresis; 2 = paralysis), giving a maximum score of 6.
The total maximum sensorimotor score is 14. Successful block is defined as a total score ≥12/14 with a sensory score ≥7/8. Blocks not achieving success criteria within 60 minutes will be considered failed. Patients with a successful block will then be transferred to the operating room.
Statistical Analysis Continuous variables will be assessed for normality using the Shapiro-Wilk test. Normally distributed variables will be compared using the independent samples t-test; non-normally distributed variables using the Mann-Whitney U test. Categorical variables will be analyzed using Fisher's exact chi-square test. A p-value <0.05 will be considered statistically significant. Statistical analyses will be performed using SPSS (IBM, Armonk, NY) or R (v4.2, Vienna, Austria).
- Conditions
- Lower Extremity, Nerve Block, Pain, Postoperative, Pain, Nerve
- Being tested
- Bupivacaine-Lidocaine Combination, Bupivacaine
- Keywords
- Popliteal sciatic nerve block, Bupivacaine, Lidocaine, Local anesthetic, Ultrasound-guided nerve block, Regional anesthesia, Postoperative analgesia, Block onset time, Lower extremity surgery, QoR-15
- Medical subject headings
- Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-Lidocaine CombinationDrug
Also called Lidocaine 2% + Bupivacaine 0.5%
Ultrasound-guided popliteal sciatic nerve block with 10 mL 2% lidocaine and 10 mL 0.5% bupivacaine administered sequentially in separate syringes (total volume: 20 mL).
BupivacaineDrug
Also called Bupivacaine 0.5%
Ultrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two separate 10 mL syringes (total volume: 20 mL).
| Study group | Role | What they receive |
|---|---|---|
| Group BL (Bupivacaine-Lidocaine) | Experimental | Ultrasound-guided popliteal sciatic nerve block with 10 mL 2% lidocaine + 10 mL 0.5% bupivacaine administered sequentially in separate syringes (total volume: 20 mL). Receives: Drug: Bupivacaine-Lidocaine Combination |
| Group B (Bupivacaine Alone) | Active comparator | Ultrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two 10 mL syringes (total volume: 20 mL). Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Sensory Block
Time to return of sensation in the postoperative period, defined as the time at which the patient first reports regaining sensation in the toes. Sensory function will be assessed at 1, 2, 4, 8, 12, and 24 hours postoperatively by an outcome assessor blinded to group allocation, and the time of sensory recovery will be confirmed by in-person visit or telephone interview at 24, 48, and 72 hours after block performance.
Measured: Postoperative 1, 2, 4, 8, 12, and 24 hours; confirmed at 24, 48, and 72 hours after block performance
Secondary outcomes (12)
Block Success Rate
Proportion of patients achieving a total sensorimotor score ≥12/14 with a sensory score ≥7/8 within 60 minutes of injection.
Measured: Within 60 minutes after injection
Duration of Motor Block
Time to return of motor function in the postoperative period, defined as the time at which the patient is first able to move the toes. Motor function will be assessed at 1, 2, 4, 8, 12, and 24 hours postoperatively and confirmed by in-person visit or telephone interview at 24, 48, and 72 hours after block performance.
Measured: Up to 72 hours after block application
Postoperative Pain Score
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain) at 1, 2, 4, 8, 12, and 24 hours postoperatively. The highest NRS score will additionally be recorded at 24, 48, and 72 hours after block performance.
Measured: At 1, 2, 4, 8, 12, 24, 48, and 72 hours postoperatively
Quality of Recovery-15 (QoR-15) Score
Patient-reported quality of recovery assessed using the validated QoR-15 questionnaire, comprising 15 items across five dimensions (physical comfort, physical independence, psychological support, emotional state, and pain). Total score ranges from 0 to 150, with higher scores indicating better recovery. The questionnaire will be administered preoperatively (baseline) and at 24 hours postoperatively.
Measured: Preoperatively (baseline) and at 24 hours postoperatively
Incidence of Rebound Pain
Proportion of patients experiencing rebound pain, defined as NRS ≥7 within 24 hours after resolution of the sensory block.
Measured: Within 24 hours after sensory block resolution, up to 72 hours postoperatively
Neurological Assessment at Postoperative Day 7
Presence of any neurological sequelae including paresthesia, numbness, or motor deficit in the blocked extremity, assessed by telephone interview or clinic visit at postoperative day 7.
Measured: Postoperative day 7
Sensory and Motor Block Onset Time
Time elapsed from completion of local anesthetic injection to first achievement of block success criteria, defined as a total sensorimotor score ≥12/14 and sensory score ≥7/8. Blocks not meeting success criteria within 60 minutes will be considered failed.
Measured: From completion of injection up to 60 minutes
Adequacy of Surgical Anesthesia
Proportion of patients in whom surgery is completed without the need for supplemental general anesthesia or local infiltration at the surgical site.
Measured: Intraoperative
Duration of Analgesia
Time to first reported pain after block performance, recorded by patient interview and confirmed by in-person visit or telephone interview at 24, 48, and 72 hours after block performance.
Measured: Up to 72 hours after block performance
Postoperative Pain Assessed by Visual Analogue Scale (VAS)
Postoperative pain intensity assessed using a 10-cm Visual Analogue Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at 1, 2, 4, 8, 12, and 24 hours postoperatively by an outcome assessor blinded to group allocation.
Measured: At 1, 2, 4, 8, 12, and 24 hours postoperatively
Time to First Postoperative Mobilization
Time elapsed from the end of surgery to the patient's first mobilization, defined as getting out of bed and ambulating with or without assistance (including the use of crutches or a walker, according to the weight-bearing status prescribed by the surgical team). The time of first mobilization will be recorded by an outcome assessor blinded to group allocation and confirmed by patient interview.
Measured: From the end of surgery up to 72 hours postoperatively
Time to First Rescue Opioid Requirement
Time elapsed from the end of surgery to the first administration of intravenous rescue tramadol, given when the postoperative pain score reaches NRS ≥4. Patients who do not require rescue opioid analgesia during the follow-up period will be recorded as censored at 72 hours.
Measured: From the end of surgery up to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing elective distal lower extremity surgery will be randomized in a 1:1 ratio into two parallel groups. Group BL will receive ultrasound-guided popliteal sciatic nerve block with bupivacaine-lidocaine combination; Group B will receive bupivacaine alone.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
- Investigators
- AHMET MURAT YAYIK, MD, PhD, Principal investigator, Ataturk University Faculty of Medicine, Department of Anesthesiology and ReanimationASLIHAN BOROGLU, MD, Principal investigator, Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550348
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/927
- Acronym
- PSSNB-BL
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wieder B, Arbisfeld J. Overriding Safety Controls. Am J Nurs. 2023 Nov 1;123(11):9. doi: 10.1097/01.NAJ.0000995280.93037.b9. No abstract available.
PubMed 37882382Gallipoli A, MacLean G, Walia JS, Sehgal A. Congenital Chylothorax and Hydrops Fetalis: A Novel Neonatal Presentation of RASA1 Mutation. Pediatrics. 2021 Mar;147(3):e2020011601. doi: 10.1542/peds.2020-011601.
PubMed 33608416Occhipinti G, Ruberti AA, Alcocer J, Gimenez-Mila M, Vidal B, Regueiro A. Sex differences in patients undergoing aortic valve replacement: a tale of 2 hearts. Rev Esp Cardiol (Engl Ed). 2025 Oct;78(10):916-918. doi: 10.1016/j.rec.2025.01.014. Epub 2025 Feb 6. No abstract available. English, Spanish.
PubMed 39922556
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine-Lidocaine Combination Versus Bupivacaine Alone for Ultrasound-Guided Popliteal Sciatic Nerve Block in Elective Lower Extremity Surgery: A Prospective Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07550348
- Acronym / sponsor ID
- PSSNB-BL / B.30.2.ATA.0.01.00/927
- Conditions
- Lower Extremity, Nerve Block, Pain, Postoperative, Pain, Nerve
- Keywords
- Popliteal sciatic nerve block, Bupivacaine, Lidocaine, Local anesthetic, Ultrasound-guided nerve block, Regional anesthesia, Postoperative analgesia, Block onset time
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized, double-blind clinical trial aims to compare the efficacy of two local anesthetic regimens for ultrasound-guided popliteal sciatic nerve block in adult patients undergoing elective distal lower extremity surgery.
Eligible participants (ages 18-65, ASA physical status I-III, BMI 18-35 kg/m²) will be randomized into two equal groups of 30. Patients in Group BL will receive a combination of 10 mL 2% lidocaine and 10 mL 0.5% bupivacaine, while patients in Group B will receive 20 mL 0.5% bupivacaine alone, administered via ultrasound-guided popliteal sciatic nerve block prior to surgery.
The primary outcome is the onset time of sensory and motor blockade. Secondary outcomes include block success rate, duration of sensory and motor block, postoperative opioid consumption, pain scores assessed by the Numeric Rating Scale (NRS) at 2, 4, 8, 12, and 24 hours postoperatively, Quality of Recovery-15 (QoR-15) score, and incidence of rebound pain.
The study is conducted at Ataturk University Research Hospital, Department of Anesthesiology and Reanimation, Erzurum, Turkey.
Detailed description
Background and Rationale
Peripheral nerve blocks have become an increasingly preferred technique for both anesthesia and analgesia in distal lower extremity surgery, offering advantages such as reduced opioid consumption, stable intraoperative hemodynamics, lower rates of postoperative nausea and vomiting, and enhanced early mobilization. The popliteal approach to the sciatic nerve provides effective surgical anesthesia for foot, ankle, and distal leg procedures, with high patient satisfaction and a low complication profile. Ultrasound guidance further improves block success rates by enabling direct visualization of perineural anatomical structures.
The choice of local anesthetic plays a critical role in determining block onset time, duration of sensory and motor blockade, and overall analgesic duration. Lidocaine offers rapid onset and short-to-intermediate duration, while bupivacaine provides prolonged sensory and motor blockade, thereby reducing postoperative opioid requirements. The combination of these two agents theoretically enables simultaneous achievement of rapid onset and prolonged analgesia; however, the net effect of this combination on block characteristics remains inconclusive in the current literature.
Study Design
This is a prospective, randomized, double-blind, single-center, two-arm parallel-group clinical trial conducted at Ataturk University Research Hospital, Department of Anesthesiology and Reanimation, Erzurum, Turkey.
Participants
A total of 60 adult patients scheduled for elective distal lower extremity surgery will be enrolled. Inclusion criteria: age 18-65 years, ASA physical status I-III, body mass index (BMI) 18-35 kg/m², and written informed consent. Exclusion criteria include inability to provide informed consent, coagulopathy, sepsis, hepatic or renal insufficiency, known allergy to local anesthetics, prior surgery or significant scar tissue in the popliteal fossa, pregnancy, and chronic opioid use at home.
Randomization and Blinding
Eligible patients will be randomized in a 1:1 ratio using a computer-generated random number list into two groups of 30. Study solutions will be prepared by a dedicated investigator not involved in block performance or outcome assessment. Patients and the outcome assessor will be blinded to group allocation (double-blind). The anesthesiologist performing the block will be aware of the group allocation. Block procedures will be performed by an anesthesiologist with a minimum of two years of experience in ultrasound-guided regional anesthesia who is not involved in patient care.
Intervention
All patients will receive an ultrasound-guided popliteal sciatic nerve block using a total volume of 20 mL local anesthetic solution. Patients will be positioned prone or in lateral decubitus with the operative limb uppermost and the knee in slight flexion. Under aseptic conditions, a high-frequency linear ultrasound probe will be placed transversely over the popliteal fossa to visualize the popliteal artery and the tibial nerve. The probe will be advanced proximally to identify the tibial and common peroneal nerve bifurcation. A 100 mm echogenic block needle will be advanced in-plane from lateral to medial. After confirming circumferential perineural spread of 1-2 mL test injection under ultrasound guidance, the study solution will be incrementally injected with repeated aspiration checks.
Group BL (n=30): 10 mL 2% lidocaine + 10 mL 0.5% bupivacaine (administered sequentially in separate syringes)
Group B (n=30): 20 mL 0.5% bupivacaine (administered in two 10 mL syringes) In cases involving the medial malleolus or medial leg surface, an additional adductor canal block will be performed using 10 mL of the respective study solution.
Intraoperative Management Conscious sedation will be maintained intraoperatively with intravenous dexmedetomidine (loading dose: 0.5-1 µg/kg over 10 minutes; maintenance: 0.2-0.7 µg/kg/hour). Continuous monitoring of heart rate, non-invasive blood pressure, oxygen saturation, and electrocardiography will be performed throughout the procedure.
Postoperative Analgesia Protocol All patients will receive intravenous paracetamol 1000 mg 30 minutes before the end of surgery, repeated every 8 hours postoperatively. Intravenous dexketoprofen 50 mg will be administered intraoperatively and repeated every 12 hours. Rescue analgesia with intravenous tramadol 100 mg will be administered for NRS ≥ 4, with a maximum of 3 doses per day and a minimum interval of 4-6 hours between doses.
Outcome Measures Primary Outcome: The primary outcome is the duration of sensory block. It is defined as the time to return of sensation in the postoperative period, i.e., the time at which the patient first reports regaining sensation in the toes. Sensory function will be assessed at 1, 2, 4, 8, 12, and 24 hours postoperatively. The time of sensory recovery will be confirmed by in-person visit or telephone interview at 24, 48, and 72 hours after block performance.
Secondary Outcomes:
Block onset time: Time elapsed from completion of local anesthetic injection to first achievement of block success criteria.
Block success rate: Proportion of patients achieving a total sensorimotor score ≥12/14 with a sensory score ≥7/8 within 60 minutes of injection.
Adequacy of surgical anesthesia: Completion of surgery without the need for supplemental general anesthesia or local infiltration at the surgical site.
Duration of motor block: Time to return of motor function in the postoperative period, i.e., the time at which the patient is first able to move the toes. Motor function will be assessed at 1, 2, 4, 8, 12, and 24 hours postoperatively.
Duration of analgesia: Time to first reported pain after block performance. Postoperative pain scores: Pain intensity assessed using the Numeric Rating Scale (NRS 0-10) at 1, 2, 4, 8, 12, and 24 hours postoperatively. The highest NRS score will additionally be recorded at 24, 48, and 72 hours.
Quality of recovery: QoR-15 score (0-150; higher scores indicate better recovery) assessed preoperatively (baseline) and at 24 hours postoperatively.
Incidence of rebound pain: Defined as NRS ≥7 within 24 hours after resolution of the sensory block.
Neurological complications: Presence of paresthesia, numbness, or motor deficit in the blocked extremity, assessed by telephone interview or outpatient clinic visit on postoperative day 7.
Block Assessment
Sensory block will be assessed using the pinprick test across four nerve territories: tibial (plantar aspect of the foot), deep peroneal (first web space), superficial peroneal (dorsum of the foot), and sural (lateral border of the fifth metatarsal). Each territory will be scored from 0 to 2 (0 = normal sensation; 1 = analgesia, i.e., the patient perceives touch but not pinprick; 2 = anesthesia, i.e., the patient perceives neither touch nor pinprick), giving a maximum score of 8.
Motor block will be evaluated across three nerve territories: tibial (ankle plantar flexion), deep peroneal (ankle dorsiflexion), and superficial peroneal (foot eversion). Each territory will be scored from 0 to 2 (0 = normal; 1 = paresis; 2 = paralysis), giving a maximum score of 6.
The total maximum sensorimotor score is 14. Successful block is defined as a total score ≥12/14 with a sensory score ≥7/8. Blocks not achieving success criteria within 60 minutes will be considered failed. Patients with a successful block will then be transferred to the operating room.
Statistical Analysis Continuous variables will be assessed for normality using the Shapiro-Wilk test. Normally distributed variables will be compared using the independent samples t-test; non-normally distributed variables using the Mann-Whitney U test. Categorical variables will be analyzed using Fisher's exact chi-square test. A p-value <0.05 will be considered statistically significant. Statistical analyses will be performed using SPSS (IBM, Armonk, NY) or R (v4.2, Vienna, Austria).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing elective distal lower extremity surgery will be randomized in a 1:1 ratio into two parallel groups. Group BL will receive ultrasound-guided popliteal sciatic nerve block with bupivacaine-lidocaine combination; Group B will receive bupivacaine alone.
| Arm | Type | Receives |
|---|---|---|
| Group BL (Bupivacaine-Lidocaine) | Experimental | Drug: Bupivacaine-Lidocaine CombinationUltrasound-guided popliteal sciatic nerve block with 10 mL 2% lidocaine + 10 mL 0.5% bupivacaine administered sequentially in separate syringes (total volume: 20 mL). |
| Group B (Bupivacaine Alone) | Active comparator | Drug: BupivacaineUltrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two 10 mL syringes (total volume: 20 mL). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III
- Scheduled for elective distal lower extremity surgery (below-knee)
- Body mass index (BMI) between 18 and 35 kg/m²
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Refusal to participate in the study
- Morbid obesity (BMI ≥35 kg/m²)
- Known allergy or hypersensitivity to any local anesthetic agent
- Severe cardiac, hepatic, or renal disease
- Pre-existing neurological deficits or peripheral neuropathy
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 |
|---|---|---|
| Bupivacaine-Lidocaine CombinationAlso: Lidocaine 2% + Bupivacaine 0.5%Ultrasound-guided popliteal sciatic nerve block with 10 mL 2% lidocaine and 10 mL 0.5% bupivacaine administered sequentially in separate syringes (total volume: 20 mL). | Drug | Group BL (Bupivacaine-Lidocaine) |
| BupivacaineAlso: Bupivacaine 0.5%Ultrasound-guided popliteal sciatic nerve block with 20 mL 0.5% bupivacaine administered in two separate 10 mL syringes (total volume: 20 mL). | Drug | Group B (Bupivacaine Alone) |
Primary outcome
Duration of Sensory Block
Time frame: Postoperative 1, 2, 4, 8, 12, and 24 hours; confirmed at 24, 48, and 72 hours after block performance
Time to return of sensation in the postoperative period, defined as the time at which the patient first reports regaining sensation in the toes. Sensory function will be assessed at 1, 2, 4, 8, 12, and 24 hours postoperatively by an outcome assessor blinded to group allocation, and the time of sensory recovery will be confirmed by in-person visit or telephone interview at 24, 48, and 72 hours after block performance.
12 secondary outcomes
Block Success Rate
Time frame: Within 60 minutes after injection
Duration of Motor Block
Time frame: Up to 72 hours after block application
Postoperative Pain Score
Time frame: At 1, 2, 4, 8, 12, 24, 48, and 72 hours postoperatively
Quality of Recovery-15 (QoR-15) Score
Time frame: Preoperatively (baseline) and at 24 hours postoperatively
Incidence of Rebound Pain
Time frame: Within 24 hours after sensory block resolution, up to 72 hours postoperatively
Neurological Assessment at Postoperative Day 7
Time frame: Postoperative day 7
Sensory and Motor Block Onset Time
Time frame: From completion of injection up to 60 minutes
Adequacy of Surgical Anesthesia
Time frame: Intraoperative
Duration of Analgesia
Time frame: Up to 72 hours after block performance
Postoperative Pain Assessed by Visual Analogue Scale (VAS)
Time frame: At 1, 2, 4, 8, 12, and 24 hours postoperatively
Time to First Postoperative Mobilization
Time frame: From the end of surgery up to 72 hours postoperatively
Time to First Rescue Opioid Requirement
Time frame: From the end of surgery up to 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 37882382Wieder B, Arbisfeld J. Overriding Safety Controls. Am J Nurs. 2023 Nov 1;123(11):9. doi: 10.1097/01.NAJ.0000995280.93037.b9. No abstract available.
- Background: PubMed 33608416Gallipoli A, MacLean G, Walia JS, Sehgal A. Congenital Chylothorax and Hydrops Fetalis: A Novel Neonatal Presentation of RASA1 Mutation. Pediatrics. 2021 Mar;147(3):e2020011601. doi: 10.1542/peds.2020-011601.
- Background: PubMed 39922556Occhipinti G, Ruberti AA, Alcocer J, Gimenez-Mila M, Vidal B, Regueiro A. Sex differences in patients undergoing aortic valve replacement: a tale of 2 hearts. Rev Esp Cardiol (Engl Ed). 2025 Oct;78(10):916-918. doi: 10.1016/j.rec.2025.01.014. Epub 2025 Feb 6. No abstract available. English, Spanish.
- Individual participant dataSharing planned: No
Related trials for Lower Extremity
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
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.
AHMET MURAT YAYIK, MD, PhD principal investigator
Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation
ASLIHAN BOROGLU, MD principal investigator
Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine-Lidocaine Combination and Bupivacaine in people with Lower Extremity and Nerve Block, run by Ataturk 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 5 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AHMET MURAT YAYIK, MD, PhD (+95544259287, ahmetmuratyayik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Sensory Block (time frame: Postoperative 1, 2, 4, 8, 12, and 24 hours; confirmed at 24, 48, and 72 hours after block performance). 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 NCT07550348, which also lists 3 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 19 Oct 2026.