AnesthesiaNCT01734954
Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery
A study testing Sciatic nerve anesthesia blockade at bifurcation., Sciatic nerve blockade 2 cm beyond the bifurcation and Levobupivacaine 0.5%: 20 ml in people with Anesthesia, run by CES University at 2 sites in Colombia.
Trial summary
The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sciatic nerve anesthesia blockade at bifurcation., Sciatic nerve blockade 2 cm beyond the bifurcation and Levobupivacaine 0.5%: 20 ml
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesColombia
- Study dates
- Apr 2013to Sep 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica CES.
- Physical status classification of the American Society of Anesthesiologists (ASA) 1-3.
- Age: 18-70 years.
- Weight: 40-100 kg
- Taller than 140 cm.
Who cannot join
- No patient acceptance.
- Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture).
- Neuropathy or myopathy affecting the lower limb.
- Psychiatric or neurological diseases that alter the evaluation of patient.
- Arrhythmias.
- Heart failure.
Show all 10Show fewer
- Diabetes Mellitus.
- Pregnancy.
- Language barriers.
- Anticoagulation.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Hospital Pablo Tobón Uribe
Medellín, Antioquia, 050034
Marta I Berrio, MD, +57 3014839308, martaberrio@gmail.com
Marta I Berrio, MD
Clínica CES
Medellín, Antioquia
About this study
Official title: Comparison of Two Techniques of Ultrasound-guided Sciatic Nerve Block Using Levobupivacaine 0.5% in Orthopedic Surgery at the Hospital Pablo Tobon Uribe - Clínica CES, 2013, Randomized Clinical Trial
The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. Our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.
Read the detailed description
Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is the latency period of the nerve blockade; the secondary outcomes are rate of success of the procedure as well as patient satisfaction.
- Conditions
- Anesthesia
- Being tested
- Sciatic nerve anesthesia blockade at bifurcation., Sciatic nerve blockade 2 cm beyond the bifurcation, Levobupivacaine 0.5%: 20 ml, Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA, Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)
- Keywords
- Nerve block, Sciatic nerve, Ultrasonography, Orthopedics, Hallux Valgus, Amputation, Arthrodesis, Arthroscopy, Fracture fixation, Osteotomy, Tendon transfer, Tenodesis, Tenotomy, Orthopedic procedure
- Medical subject headings
- Hallux Valgus, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic nerve anesthesia blockade at bifurcation.Procedure or surgery
Also called Sciatic Nerve Block
A proximal and distal initial scan and define the site to block the bifurcation. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% and a total volume of 20 mL.
Sciatic nerve blockade 2 cm beyond the bifurcationProcedure or surgery
Also called Sciatic nerve block
A proximal and distal initial scan and define the sites to block: tibial and peroneal nerves separate distal 2 cm from the bifurcation site. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% 10 mL tibial nerve and 10 mL to the peroneal nerve.
Levobupivacaine 0.5%: 20 mlDrug
Also called Local Anesthetic
Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WADevice
Also called Ultrasound
An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)Device
Also called Nerve blockade needle short bevel.
This is a specific kind of needle that is widely used for anesthesia nerve blockade.
supplemental oxygenDrug
Also called oxygen
supplemental oxygen during the block and/or during surgery
MidazolamDrug
Intravenous midazolam for sedation during the block and/or during surgery
Intravenous analgesicsDrug
Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg
Saphenous nerve blockProcedure or surgery
Depending on sensitive territory committed by the type of surgery suprapatellar saphenous nerve block guided by ultrasound with 100 mm Stimuplex needle and injection of levobupivacaine 0.5% (total volume: 5 ml).
| Study group | Role | What they receive |
|---|---|---|
| Sciatic nerve blockade at bifurcation | Experimental | Ultrasound-guided block at the bifurcation of the sciatic nerve Receives: Procedure: Sciatic nerve anesthesia blockade at bifurcation.; Drug: Levobupivacaine 0.5%: 20 ml; Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA; Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany); Drug: supplemental oxygen; Drug: Midazolam; Drug: Intravenous analgesics; Procedure: Saphenous nerve block |
| Sciatic block 2 cm beyond bifurcation | Experimental | Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation Receives: Procedure: Sciatic nerve blockade 2 cm beyond the bifurcation; Drug: Levobupivacaine 0.5%: 20 ml; Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA; Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany); Drug: supplemental oxygen; Drug: Midazolam; Drug: Intravenous analgesics; Procedure: Saphenous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency period of sciatic nerve block.
Once the nerve blockade is done, a sensory evaluation will be performed in the surgical area every five minutes to determine the onset of the sensory nerve blockade in minutes.
Measured: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.
Secondary outcomes (17)
Success of sciatic nerve block
The time to achieve a complete sensory nerve block, reached maximum at 30 minutes, in full distribution of tibial nerve and common fibular nerve for anesthesia.
Measured: Every 5 minutes until 30 minutes until the end of the procedure for the nerve block; an additional measure will be performed at the end of of the surgery.
Patient satisfaction
Using a categorical score we will measure satisfaction of nerve-block-procedure satisfaction and analgesia quality one day after surgery: patients will choose one of three options: no satisfied, satisfied or very satisfied.
Measured: Postoperative 24 hours
Sensory block
Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves
0: Complete sensory block
- Almost complete sensory block: Decreased sensation to pinprick with a 24 gauge hypodermic needle
- Feeling normal (for each component: tibial and common peroneal) compared with the contralateral leg
Measured: 5, 10, 15, 20, 25 and 30 minutes after the block is finished
Motor block
Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves 0: Complete motor blockade
- Motor block almost complete
- No motor block (for the tibial component for plantarflexion and dorsiflexion with the common peroneal) compared with the contralateral leg
Measured: 5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished
First analgesic
Time of first analgesic requirement in postoperative
Measured: 5 minutes, 30 minutes, 24 hours postoperative
Visual analog scale at rest
Pain rating ranging from zero to ten VAS 0: no pain VAS 1-3: Mild pain VAS 4-6: Moderate Pain VAS 7-10: Severe pain
Measured: 5 minutes, 30 minutes, 24 hours postoperative
Dynamic visual analog scale
Pain rating ranging from zero to ten with the movement
Measured: 5 minutes, 30 minutes, 24 hours postoperative
Intraneural injection
Increased diameter nerve or visualized by ultrasound visualization of the needle into the nerve at the time of injection
Measured: At the time of injection and execution of the block
Vascular puncture
Puncture of one or more blood vessels to visualize the needle within the vessel or to aspirate blood during block
Measured: During the execution of the block
Paresthesia during the procedure
Paresthesia during the procedure
Measured: At the time of the execution of the block
Systemic toxicity of local anesthetics
Systemic toxicity of local anesthetics
Measured: During the execution of the block and 30 minutes after it
Hematoma
Hematoma
Measured: During and inmmediately after the execution of the block
Muscle weakness
Subjective reduction in muscle strength at 24 hours postoperative
Measured: 24 hours postoperative
Altered sensitivity
Subjective decreased sensitivity at 24 hours postoperative
Measured: 24 hours postoperative
Cramps postoperative
Feeling cramps within 24 hours of the block
Measured: 24 hours postoperative of the block
Punctures
Number of skin punctures during the block
Measured: During the block
Time for the execution of nerve block
Time from placement of the transducer for the initial scan to final withdrawal of the needle
Measured: In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe, Clínica CES
- Responsible party
- Principal investigator, Marta Inés Berrío Valencia, CES University
- Investigators
- Marta I Berrio, MD, Principal investigator, CES University, Medellín, Antioquia, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734954
- Sponsor's protocol ID
- IACES
- Status last verified
- Apr 2013
- First submitted
- 10 Nov 2012
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques of Ultrasound-guided Sciatic Nerve Block Using Levobupivacaine 0.5% in Orthopedic Surgery at the Hospital Pablo Tobon Uribe - Clínica CES, 2013, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01734954
- Acronym / sponsor ID
- IACES
- Conditions
- Anesthesia
- Keywords
- Nerve block, Sciatic nerve, Ultrasonography, Orthopedics, Hallux Valgus, Amputation, Arthrodesis, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe, Clínica CES
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. Our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.
Detailed description
Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is the latency period of the nerve blockade; the secondary outcomes are rate of success of the procedure as well as patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sciatic nerve blockade at bifurcation | Experimental | Procedure: Sciatic nerve anesthesia blockade at bifurcation., Drug: Levobupivacaine 0.5%: 20 ml, Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA, Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany), Drug: supplemental oxygen, Drug: Midazolam, Drug: Intravenous analgesics, Procedure: Saphenous nerve blockUltrasound-guided block at the bifurcation of the sciatic nerve |
| Sciatic block 2 cm beyond bifurcation | Experimental | Procedure: Sciatic nerve blockade 2 cm beyond the bifurcation, Drug: Levobupivacaine 0.5%: 20 ml, Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA, Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany), Drug: supplemental oxygen, Drug: Midazolam, Drug: Intravenous analgesics, Procedure: Saphenous nerve blockUltrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica CES.
- Physical status classification of the American Society of Anesthesiologists (ASA) 1-3.
- Age: 18-70 years.
- Weight: 40-100 kg
- Taller than 140 cm.
Key exclusion criteria (10 listed)
- No patient acceptance.
- Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture).
- Neuropathy or myopathy affecting the lower limb.
- Psychiatric or neurological diseases that alter the evaluation of patient.
- Arrhythmias.
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 |
|---|---|---|
| Sciatic nerve anesthesia blockade at bifurcation.Also: Sciatic Nerve BlockA proximal and distal initial scan and define the site to block the bifurcation. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% and a total volume of 20 mL. | Procedure or surgery | Sciatic nerve blockade at bifurcation |
| Sciatic nerve blockade 2 cm beyond the bifurcationAlso: Sciatic nerve blockA proximal and distal initial scan and define the sites to block: tibial and peroneal nerves separate distal 2 cm from the bifurcation site. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% 10 mL tibial nerve and 10 mL to the peroneal nerve. | Procedure or surgery | Sciatic block 2 cm beyond bifurcation |
| Levobupivacaine 0.5%: 20 mlAlso: Local AnestheticLevobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade. | Drug | Sciatic block 2 cm beyond bifurcation, Sciatic nerve blockade at bifurcation |
| Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WAAlso: UltrasoundAn ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade. | Device | Sciatic block 2 cm beyond bifurcation, Sciatic nerve blockade at bifurcation |
| Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)Also: Nerve blockade needle short bevel.This is a specific kind of needle that is widely used for anesthesia nerve blockade. | Device | Sciatic block 2 cm beyond bifurcation, Sciatic nerve blockade at bifurcation |
| supplemental oxygenAlso: oxygensupplemental oxygen during the block and/or during surgery | Drug | Sciatic block 2 cm beyond bifurcation, Sciatic nerve blockade at bifurcation |
| MidazolamIntravenous midazolam for sedation during the block and/or during surgery | Drug | Sciatic block 2 cm beyond bifurcation, Sciatic nerve blockade at bifurcation |
| Intravenous analgesicsIntraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg | Drug | Sciatic block 2 cm beyond bifurcation, Sciatic nerve blockade at bifurcation |
| Saphenous nerve blockDepending on sensitive territory committed by the type of surgery suprapatellar saphenous nerve block guided by ultrasound with 100 mm Stimuplex needle and injection of levobupivacaine 0.5% (total volume: 5 ml). | Procedure or surgery | Sciatic block 2 cm beyond bifurcation, Sciatic nerve blockade at bifurcation |
Primary outcome
Latency period of sciatic nerve block.
Time frame: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.
Once the nerve blockade is done, a sensory evaluation will be performed in the surgical area every five minutes to determine the onset of the sensory nerve blockade in minutes.
17 secondary outcomes
Success of sciatic nerve block
Time frame: Every 5 minutes until 30 minutes until the end of the procedure for the nerve block; an additional measure will be performed at the end of of the surgery.
Patient satisfaction
Time frame: Postoperative 24 hours
Sensory block
Time frame: 5, 10, 15, 20, 25 and 30 minutes after the block is finished
Motor block
Time frame: 5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished
First analgesic
Time frame: 5 minutes, 30 minutes, 24 hours postoperative
Visual analog scale at rest
Time frame: 5 minutes, 30 minutes, 24 hours postoperative
Dynamic visual analog scale
Time frame: 5 minutes, 30 minutes, 24 hours postoperative
Intraneural injection
Time frame: At the time of injection and execution of the block
Vascular puncture
Time frame: During the execution of the block
Paresthesia during the procedure
Time frame: At the time of the execution of the block
Systemic toxicity of local anesthetics
Time frame: During the execution of the block and 30 minutes after it
Hematoma
Time frame: During and inmmediately after the execution of the block
Muscle weakness
Time frame: 24 hours postoperative
Altered sensitivity
Time frame: 24 hours postoperative
Cramps postoperative
Time frame: 24 hours postoperative of the block
Punctures
Time frame: During the block
Time for the execution of nerve block
Time frame: In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
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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.
Marta I Berrio, MD principal investigator
CES University, Medellín, Antioquia, Colombia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sciatic nerve anesthesia blockade at bifurcation., Sciatic nerve blockade 2 cm beyond the bifurcation and Levobupivacaine 0.5%: 20 ml in people with Anesthesia, run by CES University at 2 sites in Colombia.
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 10 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: status not confirmed, as of the sponsor's last update on 19 Apr 2013. 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 Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta I Berrio, MD (+57 301 4839308, martaberrio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency period of sciatic nerve block. (time frame: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.