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

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

Study Locations

    • Kafrelsheikh
      • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
        • Recruiting
        • Kafrelsheikh University
        • Contact:

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:
  • Bupivacaine 0.5%
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:
  • Bupivacaine 0.5%

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.

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

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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