Nerve PainNCT06489210
A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block
A study testing popliteal block in people with Nerve Pain, run by Helwan University at 1 site in Egypt.
Trial summary
Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Pain
- What is being tested?
- popliteal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 30 Apr 2021
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status (PS) class I and II
- weighing 70-85 kg,
- undergoing elective below knee surgeries
Who cannot join
- patients who refused to participate in the study
- those having an allergy to local anesthetics
- peripheral neuropathy, coagulopathy
- diabetes mellitus
- severe hepatic
- renal impairment
- infection, mass and crush injury or open wound at the nerve block site
- patients receiving chronic analgesic therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block: A Randomized Clinical Study
Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.
Read the detailed description
Methods: In this randomized, controlled clinical trial, one hundred and twenty ASA physical status of class I and II patients undergoing below-knee surgery were involved. These patients were divided into three equal groups at randomly based on the route assigned for the US-guided popliteal block: the posterior, lateral, and medial approach groups. In this study, technical characteristics [number of attempts to get the proper injection site and block performance time], anesthetic and analgesic characteristics [success rate, block onset, potency, and duration, time to ask, and the consumed amount of postoperative analgesia], discomfort rate in respect to position and needle insertion and the associated complications were recorded.
- Conditions
- Nerve Pain
- Being tested
- popliteal block
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
popliteal blockProcedure or surgery
using ultrasound to detect sciatic nerve and popliteal fossa through different approaches using 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally
| Study group | Role | What they receive |
|---|---|---|
| popliteal block posterior approach group | Active comparator | through posterior approach ultrasound guided sciatic nerve block at popliteal fossa 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally Receives: Procedure: popliteal block |
| popliteal block lateral approach group | Active comparator | ultrasound guided sciatic nerve block at popliteal fossa through lateral approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally Receives: Procedure: popliteal block |
| poplitea block medial approach group | Active comparator | ultrasound guided sciatic nerve block at popliteal fossa through medial approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally Receives: Procedure: popliteal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of intraoperative and postoperative pain in different groups after intervention
pain severity levels via visual analogue scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient was asked to mark on this line where the intensity of the patient lies
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Apr 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Ali Hassan, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489210
- Sponsor's protocol ID
- 4428-4-3-2018
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06489210
- Acronym / sponsor ID
- 4428-4-3-2018
- Conditions
- Nerve Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 Jul 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.
Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.
Detailed description
Methods: In this randomized, controlled clinical trial, one hundred and twenty ASA physical status of class I and II patients undergoing below-knee surgery were involved. These patients were divided into three equal groups at randomly based on the route assigned for the US-guided popliteal block: the posterior, lateral, and medial approach groups. In this study, technical characteristics [number of attempts to get the proper injection site and block performance time], anesthetic and analgesic characteristics [success rate, block onset, potency, and duration, time to ask, and the consumed amount of postoperative analgesia], discomfort rate in respect to position and needle insertion and the associated complications were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| popliteal block posterior approach group | Active comparator | Procedure: popliteal blockthrough posterior approach ultrasound guided sciatic nerve block at popliteal fossa 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally |
| popliteal block lateral approach group | Active comparator | Procedure: popliteal blockultrasound guided sciatic nerve block at popliteal fossa through lateral approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally |
| poplitea block medial approach group | Active comparator | Procedure: popliteal blockultrasound guided sciatic nerve block at popliteal fossa through medial approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status (PS) class I and II
- weighing 70-85 kg,
- undergoing elective below knee surgeries
Key exclusion criteria (8 listed)
- patients who refused to participate in the study
- those having an allergy to local anesthetics
- peripheral neuropathy, coagulopathy
- diabetes mellitus
- severe hepatic
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 |
|---|---|---|
| popliteal blockusing ultrasound to detect sciatic nerve and popliteal fossa through different approaches using 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally | Procedure or surgery | poplitea block medial approach group, popliteal block lateral approach group, popliteal block posterior approach group |
Primary outcome
assessment of intraoperative and postoperative pain in different groups after intervention
Time frame: 24 hours after operation
pain severity levels via visual analogue scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient was asked to mark on this line where the intensity of the patient lies
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 5 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing popliteal block in people with Nerve Pain, run by Helwan University 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 8 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 5 Jul 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.
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?
assessment of intraoperative and postoperative pain in different groups after intervention (time frame: 24 hours after operation). 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 5 Jul 2024.