- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06809842
Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle Versus Lateral Femoral Cutaneous Nerve After Knee Surgeries
February 5, 2025 updated by: Sherif Kamal Arafa, Kafrelsheikh University
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sherif K Arafa, MD
- Phone Number: 00201005714014
- Email: Sherifhafez1980@gmail.com
Study Locations
-
-
Kafrelsheikh
-
Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
- Recruiting
- Kafrelsheikh University
-
Contact:
- Sherif K Arafa, MD
- Phone Number: 00201005714014
- Email: Sherifhafez1980@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status from I to III.
- Underwent knee surgeries under spinal anesthesia.
Exclusion Criteria:
- Pregnancy.
- Coagulopathy.
- Neuromuscular disorders.
- Hematological disorders.
- Mental disorders.
- History of multiple traumas or anesthesia drug allergies.
- Local skin infection at the block site.
- Body mass index (BMI) greater than 40.
- Opioid analgesics or abusing opioids.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vastus lateralis nerve block group
Patients will receive vastus lateralis nerve block.
|
Patients received vastus lateralis nerve block with 5 ml of bupivacaine 0.5%.
Other Names:
|
|
Experimental: Lateral femoral cutaneous nerve block group
Patients will receive lateral femoral cutaneous nerve.
|
Patients received lateral femoral cutaneous nerve block with 5 ml of bupivacaine 0.5%.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first request for analgesia
Time Frame: 24 hours postoperatively
|
The time to first request for analgesia will be recorded from the end of surgery till the first dose of morphine is administered.
|
24 hours postoperatively
|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
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.
|
24 hours postoperatively
|
|
Block performance time
Time Frame: Intraoperatively
|
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.
|
Intraoperatively
|
|
Degree of patient satisfaction
Time Frame: 24 hours postoperatively
|
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).
|
24 hours postoperatively
|
|
Length of hospital stay
Time Frame: Till the discharge from hospital (Up to one week).
|
Length of hospital stay will be recorded from admission till discharge from the hospital.
|
Till the discharge from hospital (Up to one week).
|
|
Incidence of adverse events
Time Frame: 24 hours postoperatively
|
Incidence of adverse events such as postoperative nausea and vomiting (PONV), respiratory depression, and local anesthetic (LA) toxicity will be recorded.
|
24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2025
Primary Completion (Estimated)
July 30, 2025
Study Completion (Estimated)
July 30, 2025
Study Registration Dates
First Submitted
January 30, 2025
First Submitted That Met QC Criteria
January 30, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 5, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKSU 50-1-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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