Sciatic Nerve BlockNCT03394014
Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery
A study testing sciatic nerve block in people with Sciatic Nerve Block, run by Ain Shams University.
Trial summary
56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach or a sub gluteal approach. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Sciatic Nerve Block
- What is being tested?
- sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jul 2017
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status II and III patients
- aged 45-75 years,
- undergoing elective below knee amputation
Who cannot join
- patients who refused to participate in the study,
- those having allergy to local anaesthetics,
- or having contraindications to regional anaesthesia (having neurologic or neuromuscular disease, on anticoagulation therapy, or having skin infection at the site of needle insertion).
About this study
Official title: Ultrasound -Guided Sciatic Nerve Block in Below Knee Amputation Surgery: Subgluteal Versus Popliteal
56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach or a sub gluteal approach. Patients in both groups received same amount of LA and additional ultrasound guided femoral nerve block to ensure sensory block of the medial side of the leg. Success of the block was considered when the block is solid and doesn't require shifting to GA
Read the detailed description
56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach (group P, n 28) or a sub gluteal approach (group G, n 28). Patients in both groups received same amount of LA (25 ml of bupivacaine 0.5 %) and additional ultrasound guided femoral nerve block by 10 ml of bupivacaine 0.5% to ensure sensory block of the medial side of the leg. Time to complete sensory and motor block, time taken to perform the block, block-related complications, block duration, time for asking for rescue analgesia in the first 24 h were recorded and both patients and surgeons were asked about their level of satisfaction. Success of the block was considered when the block is solid and doesn't require shifting to GA
- Conditions
- Sciatic Nerve Block
- Being tested
- sciatic nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sciatic nerve blockProcedure or surgery
Also called sciatic nerve block at the subgluteal and popliteal region
blocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation
| Study group | Role | What they receive |
|---|---|---|
| popliteal sciatic nerve block | Active comparator | injecting 25 ml of bupivacaine 0.5 % (Sunnypivacaine, 20 ml vial contains Bupivacaine HCL Monohydrate 105.5 mg eq. to 100 mg Bupivacaine HCL, Sunny Pharmaceutical, Badr city- Cairo- Egypt) once circumferentially around the sciatic nerve at the popliteal fossa using ultrasound device (S-Nerve ultrasound system, Fujifilm Sonosite Inc., Bothell, WA) Receives: Procedure: sciatic nerve block |
| subgluteal sciatic nerve block | Active comparator | injecting 25 ml of bupivacaine 0.5 % (Sunnypivacaine, 20 ml vial contains Bupivacaine HCL Monohydrate 105.5 mg eq. to 100 mg Bupivacaine HCL, Sunny Pharmaceutical, Badr city- Cairo- Egypt) circumferentially around the sciatic nerve at the subgluteal region using ultrasound device (S-Nerve ultrasound system, Fujifilm Sonosite Inc., Bothell, WA). Receives: Procedure: sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare between the two techniques as regards the success rate.
Success was considered when the block provided solid analgesia with no need to shift to GA
Measured: 24 hours
Secondary outcomes (1)
time taken to perform the block
time required to perform either block
Measured: 10-20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Jan 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394014
- Sponsor's protocol ID
- FMASU R46/2017
- Status last verified
- Jan 2018
- First submitted
- 24 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound -Guided Sciatic Nerve Block in Below Knee Amputation Surgery: Subgluteal Versus Popliteal
- ClinicalTrials.gov ID
- NCT03394014
- Acronym / sponsor ID
- FMASU R46/2017
- Conditions
- Sciatic Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 9 Jan 2018 (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.
56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach or a sub gluteal approach. Patients in both groups received same amount of LA and additional ultrasound guided femoral nerve block to ensure sensory block of the medial side of the leg. Success of the block was considered when the block is solid and doesn't require shifting to GA
Detailed description
56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach (group P, n 28) or a sub gluteal approach (group G, n 28). Patients in both groups received same amount of LA (25 ml of bupivacaine 0.5 %) and additional ultrasound guided femoral nerve block by 10 ml of bupivacaine 0.5% to ensure sensory block of the medial side of the leg. Time to complete sensory and motor block, time taken to perform the block, block-related complications, block duration, time for asking for rescue analgesia in the first 24 h were recorded and both patients and surgeons were asked about their level of satisfaction. Success of the block was considered when the block is solid and doesn't require shifting to GA
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| popliteal sciatic nerve block | Active comparator | Procedure: sciatic nerve blockinjecting 25 ml of bupivacaine 0.5 % (Sunnypivacaine, 20 ml vial contains Bupivacaine HCL Monohydrate 105.5 mg eq. to 100 mg Bupivacaine HCL, Sunny Pharmaceutical, Badr city- Cairo- Egypt) once circumferentially around the sciatic nerve at the popliteal fossa using ultrasound device (S-Nerve ultrasound system, Fujifilm Sonosite Inc., Bothell, WA) |
| subgluteal sciatic nerve block | Active comparator | Procedure: sciatic nerve blockinjecting 25 ml of bupivacaine 0.5 % (Sunnypivacaine, 20 ml vial contains Bupivacaine HCL Monohydrate 105.5 mg eq. to 100 mg Bupivacaine HCL, Sunny Pharmaceutical, Badr city- Cairo- Egypt) circumferentially around the sciatic nerve at the subgluteal region using ultrasound device (S-Nerve ultrasound system, Fujifilm Sonosite Inc., Bothell, WA). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status II and III patients
- aged 45-75 years,
- undergoing elective below knee amputation
Key exclusion criteria (3 listed)
- patients who refused to participate in the study,
- those having allergy to local anaesthetics,
- or having contraindications to regional anaesthesia (having neurologic or neuromuscular disease, on anticoagulation therapy, or having skin infection at the site of needle insertion).
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 blockAlso: sciatic nerve block at the subgluteal and popliteal regionblocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation | Procedure or surgery | popliteal sciatic nerve block, subgluteal sciatic nerve block |
Primary outcome
to compare between the two techniques as regards the success rate.
Time frame: 24 hours
Success was considered when the block provided solid analgesia with no need to shift to GA
1 secondary outcome
time taken to perform the block
Time frame: 10-20 min
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 9 Jan 2018.
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Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sciatic nerve block in people with Sciatic Nerve Block, run by Ain Shams University.
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 3 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare between the two techniques as regards the success rate. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.