AnalgesiaNCT06809842
Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle Versus Lateral Femoral Cutaneous Nerve After Knee Surgeries
A study testing Vastus lateralis nerve block and Lateral femoral cutaneous nerve block in people with Analgesia and Vastus Lateralis Nerve Block, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to compare the analgesic efficacy and functional outcomes of blocking the nerve to the vastus lateralis (NVL) muscle versus the lateral femoral cutaneous nerve (LFCN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Vastus Lateralis Nerve Block, Lateral Femoral Cutaneous Nerve Block
- What is being tested?
- Vastus lateralis nerve block and Lateral femoral cutaneous nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2025to 30 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status from I to III.
- Underwent knee surgeries under spinal anesthesia.
Who cannot join
- Pregnancy.
- Coagulopathy.
- Neuromuscular disorders.
- Hematological disorders.
- Mental disorders.
- History of multiple traumas or anesthesia drug allergies.
Show all 9Show fewer
- Local skin infection at the block site.
- Body mass index (BMI) greater than 40.
- Opioid analgesics or abusing opioids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Sherif K Arafa, MD, 00201005714014, Sherifhafez1980@gmail.com
About this study
Official title: Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle Versus Lateral Femoral Cutaneous Nerve After Knee Surgeries: A Randomized Trial
This study aims to compare the analgesic efficacy and functional outcomes of blocking the nerve to the vastus lateralis (NVL) muscle versus the lateral femoral cutaneous nerve (LFCN).
Read the detailed description
Knee surgeries are associated with significant postoperative pain, which can impede early mobilization and prolong recovery. Recent advancements in ultrasound-guided regional anesthesia have enabled more targeted nerve blocks, such as the blockade of the nerve to the vastus lateralis (NVL) and the lateral femoral cutaneous nerve (LFCN)
- Conditions
- Analgesia, Vastus Lateralis Nerve Block, Lateral Femoral Cutaneous Nerve Block, Knee Surgeries
- Being tested
- Vastus lateralis nerve block, Lateral femoral cutaneous nerve block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vastus lateralis nerve blockDrug
Also called Bupivacaine 0.5%
Patients received vastus lateralis nerve block with 5 ml of bupivacaine 0.5%.
Lateral femoral cutaneous nerve blockDrug
Also called Bupivacaine 0.5%
Patients received lateral femoral cutaneous nerve block with 5 ml of bupivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| Vastus lateralis nerve block group | Experimental | Patients will receive vastus lateralis nerve block. Receives: Drug: Vastus lateralis nerve block |
| Lateral femoral cutaneous nerve block group | Experimental | Patients will receive lateral femoral cutaneous nerve. Receives: Drug: Lateral femoral cutaneous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Each patient will be instructed about postoperative pain assessment using the numeric rating scale (NRS) score (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS assessments will be conducted at the post-anesthesia care unit (PACU) and at 2, 4, 6, 12, 18, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Time to first request for analgesia
The time to first request for analgesia will be recorded from the end of surgery till the first dose of morphine is administered.
Measured: 24 hours postoperatively
Total morphine consumption
If the numeric rating scale (NRS) exceeded 3, rescue analgesia in the form of a 3 mg morphine bolus will be administered, to be repeated after 30 minutes if the pain persisted until the NRS dropped below 4.
Measured: 24 hours postoperatively
Block performance time
The block performance time will be recorded from the placement of the ultrasound probe to the removal of the needle after the injection of local anaesthetic.
Measured: Intraoperatively
Degree of patient satisfaction
The degree of patient satisfaction will be measured using a 5-point Likert scale (1 = extremely dissatisfied, 2 = unsatisfied, 3 = neutral, 4 = satisfied, 5 = extremely satisfied).
Measured: 24 hours postoperatively
Length of hospital stay
Length of hospital stay will be recorded from admission till discharge from the hospital.
Measured: Till the discharge from hospital (Up to one week).
Incidence of adverse events
Incidence of adverse events such as postoperative nausea and vomiting (PONV), respiratory depression, and local anesthetic (LA) toxicity will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start5 Feb 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Kamal Arafa, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809842
- Sponsor's protocol ID
- MKSU 50-1-4
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Arafa SK, Abdelwahed WM, Shama A, Elattar AM, Mustafa MM. Analgesic efficacy of blocking nerve to vastus lateralis muscle versus lateral femoral cutaneous nerve after knee surgeries: a randomized trial. BMC Anesthesiol. 2026 Mar 7;26(1):161. doi: 10.1186/s12871-026-03680-8.
PubMed 41794673
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle Versus Lateral Femoral Cutaneous Nerve After Knee Surgeries: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06809842
- Acronym / sponsor ID
- MKSU 50-1-4
- Conditions
- Analgesia, Vastus Lateralis Nerve Block, Lateral Femoral Cutaneous Nerve Block, Knee Surgeries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 5 Feb 2025 (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 study aims to compare the analgesic efficacy and functional outcomes of blocking the nerve to the vastus lateralis (NVL) muscle versus the lateral femoral cutaneous nerve (LFCN).
Detailed description
Knee surgeries are associated with significant postoperative pain, which can impede early mobilization and prolong recovery. Recent advancements in ultrasound-guided regional anesthesia have enabled more targeted nerve blocks, such as the blockade of the nerve to the vastus lateralis (NVL) and the lateral femoral cutaneous nerve (LFCN)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vastus lateralis nerve block group | Experimental | Drug: Vastus lateralis nerve blockPatients will receive vastus lateralis nerve block. |
| Lateral femoral cutaneous nerve block group | Experimental | Drug: Lateral femoral cutaneous nerve blockPatients will receive lateral femoral cutaneous nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status from I to III.
- Underwent knee surgeries under spinal anesthesia.
Key exclusion criteria (9 listed)
- Pregnancy.
- Coagulopathy.
- Neuromuscular disorders.
- Hematological disorders.
- Mental disorders.
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 |
|---|---|---|
| Vastus lateralis nerve blockAlso: Bupivacaine 0.5%Patients received vastus lateralis nerve block with 5 ml of bupivacaine 0.5%. | Drug | Vastus lateralis nerve block group |
| Lateral femoral cutaneous nerve blockAlso: Bupivacaine 0.5%Patients received lateral femoral cutaneous nerve block with 5 ml of bupivacaine 0.5%. | Drug | Lateral femoral cutaneous nerve block group |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment using the numeric rating scale (NRS) score (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS assessments will be conducted at the post-anesthesia care unit (PACU) and at 2, 4, 6, 12, 18, and 24 hours postoperatively.
6 secondary outcomes
Time to first request for analgesia
Time frame: 24 hours postoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Block performance time
Time frame: Intraoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Length of hospital stay
Time frame: Till the discharge from hospital (Up to one week).
Incidence of adverse events
Time frame: 24 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 6 Feb 2025.
- Derived from this study: PubMed 41794673Arafa SK, Abdelwahed WM, Shama A, Elattar AM, Mustafa MM. Analgesic efficacy of blocking nerve to vastus lateralis muscle versus lateral femoral cutaneous nerve after knee surgeries: a randomized trial. BMC Anesthesiol. 2026 Mar 7;26(1):161. doi: 10.1186/s12871-026-03680-8.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vastus lateralis nerve block and Lateral femoral cutaneous nerve block in people with Analgesia and Vastus Lateralis Nerve Block, run by Kafrelsheikh 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 4 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 6 Feb 2025. 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?
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 Sherif K Arafa, MD (00201005714014, Sherifhafez1980@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 24 hours postoperatively). 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 NCT06809842, which also lists 1 linked publication.
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 6 Feb 2025.