Arthroscopic Knee Ligament ReconstructionPhase 4NCT02951520
A Novel Single-puncture Triple Nerve Block; Sciatic, Obturator, Femoral Technique (SOFT), as a Sole Anesthesia for Knee Surgeries
A Phase 4 study testing new technique for lower limb nerve blocks using a single skin puncture (SOFT block) in people with Arthroscopic Knee Ligament Reconstruction, run by Healthpoint Hospital at 1 site in United Arab Emirates.
Trial summary
This study aims to describe and to evaluate the effectiveness (success rate) of a supine ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique (SOFT block) in knee surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Knee Ligament Reconstruction
- What is being tested?
- new technique for lower limb nerve blocks using a single skin puncture (SOFT block)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Oct 2016to Apr 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for arthroscopic knee ligament reconstruction
Who cannot join
- BMI > 30 kg.m-2,
- ASA physical state >II
- Allergy to the used local anesthetics
- Infection at the injection site
- age <18y
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Healthpoint Hospital
Abu Dhabi, Abu Dhabi Emirate, 112308
Sabah Zahooruddin, +971 2 4921304, s.zahooruddin@healthpoint.ae
About this study
This study aims to describe and to evaluate the effectiveness (success rate) of a supine ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique (SOFT block) in knee surgery.
Read the detailed description
Under aseptic technique, all the patients will receive US-guided femoral, obturator and sciatic nerve blocks using a single puncture point. All blocks will be performed by an expert anesthetist. The femoral nerve will be blocked lateral to the femoral artery. The obturator nerve will be blocked after it exits the obturator canal (deep to pectineus muscle). While the sciatic nerve will be blocked deep (posterior) to the inferior border of quadratus femoris muscle. The motor block of the femoral, obturator and sciatic nerves and sensory block of the lateral femoral cutaneous nerve (LFCN) will be assessed before shifting the patient to the operating room.
The performance time, patient discomfort, technique success rate, the associated successful LFCN block and any complication will be recorded by the assistant. All patients were assessed neurologically before discharge and during the physiotherapy visits for 3 weak after surgery.
- Being tested
- new technique for lower limb nerve blocks using a single skin puncture (SOFT block)
- Keywords
- Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new technique for lower limb nerve blocks using a single skin puncture (SOFT block)Procedure or surgery
The patients will be in supine position. The block needle will be inserted at the inguinal crease (medial to the femoral vein) and advanced towards the femoral nerve, then redirected towards the obturator nerve (deep to the pectineus muscle). Lastly, it will be redirected posteriorly towards the sciatic nerve (deep to the quadratus femoris muscle). A ropivacaine-lidocaine-epinephrine mixture will be used to block these nerves. The block success rate (painless surgery), performance time and patient discomfort will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| SOFT block | Experimental | Fifty patients will form the study group (one group). All the patients will receive supine ultrasound guided (US) sciatic, obturator, femoral nerve block technique using a single skin puncture (SOFT block). Receives: Procedure: new technique for lower limb nerve blocks using a single skin puncture (SOFT block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
Measured: within the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Knee Ligament ReconstructionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthpoint Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Muhammad Taha, Healthpoint Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951520
- Sponsor's protocol ID
- REC 001
- Status last verified
- Nov 2016
- First submitted
- 29 Oct 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Single-puncture Triple Nerve Block; Sciatic, Obturator, Femoral Technique (SOFT), as a Sole Anesthesia for Knee Surgeries
- ClinicalTrials.gov ID
- NCT02951520
- Acronym / sponsor ID
- REC 001
- Keywords
- Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Healthpoint HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 1 Nov 2016 (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.
This study aims to describe and to evaluate the effectiveness (success rate) of a supine ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique (SOFT block) in knee surgery.
Detailed description
Under aseptic technique, all the patients will receive US-guided femoral, obturator and sciatic nerve blocks using a single puncture point. All blocks will be performed by an expert anesthetist. The femoral nerve will be blocked lateral to the femoral artery. The obturator nerve will be blocked after it exits the obturator canal (deep to pectineus muscle). While the sciatic nerve will be blocked deep (posterior) to the inferior border of quadratus femoris muscle. The motor block of the femoral, obturator and sciatic nerves and sensory block of the lateral femoral cutaneous nerve (LFCN) will be assessed before shifting the patient to the operating room.
The performance time, patient discomfort, technique success rate, the associated successful LFCN block and any complication will be recorded by the assistant. All patients were assessed neurologically before discharge and during the physiotherapy visits for 3 weak after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOFT block | Experimental | Procedure: new technique for lower limb nerve blocks using a single skin puncture (SOFT block)Fifty patients will form the study group (one group). All the patients will receive supine ultrasound guided (US) sciatic, obturator, femoral nerve block technique using a single skin puncture (SOFT block). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for arthroscopic knee ligament reconstruction
Key exclusion criteria (5 listed)
- BMI > 30 kg.m-2,
- ASA physical state >II
- Allergy to the used local anesthetics
- Infection at the injection site
- age <18y
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 |
|---|---|---|
| new technique for lower limb nerve blocks using a single skin puncture (SOFT block)The patients will be in supine position. The block needle will be inserted at the inguinal crease (medial to the femoral vein) and advanced towards the femoral nerve, then redirected towards the obturator nerve (deep to the pectineus muscle). Lastly, it will be redirected posteriorly towards the sciatic nerve (deep to the quadratus femoris muscle). A ropivacaine-lidocaine-epinephrine mixture will be used to block these nerves. The block success rate (painless surgery), performance time and patient discomfort will be recorded. | Procedure or surgery | SOFT block |
Primary outcome
success rate
Time frame: within the perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
Related trials for Arthroscopic Knee Ligament Reconstruction
Active, not recruiting
Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament (ACL) Tear
Active, not recruiting
Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction
Anterior Cruciate Ligament Injuries
Recruiting
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Injuries
RecruitingObservational study
Augmented Reality in Surgery
Anterior Cruciate Ligament (ACL) Tear
Not yet recruiting
Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols for Arthroscopic Anterior Cruciate Ligament Reconstruction in an Ambulatory Surgery Setting
Anterior Cruciate Ligament Rupture, Enhanced Recovery After Surgery (ERAS) Protocol
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.
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 new technique for lower limb nerve blocks using a single skin puncture (SOFT block) in people with Arthroscopic Knee Ligament Reconstruction, run by Healthpoint Hospital at 1 site in United Arab Emirates.
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 1 inclusion and 5 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 3 Nov 2016. 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 United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M Taha, MD (00971508297326, ahmadtaha_1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: within the perioperative period). 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 3 Nov 2016.