NCT06809842

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

January 30, 2025

Last Update Submit

February 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours postoperatively

Secondary Outcomes (6)

  • Time to first request for analgesia

    24 hours postoperatively

  • Total morphine consumption

    24 hours postoperatively

  • Block performance time

    Intraoperatively

  • Degree of patient satisfaction

    24 hours postoperatively

  • Length of hospital stay

    Till the discharge from hospital (Up to one week).

  • +1 more secondary outcomes

Study Arms (2)

Vastus lateralis nerve block group

EXPERIMENTAL

Patients will receive vastus lateralis nerve block.

Drug: Vastus lateralis nerve block

Lateral femoral cutaneous nerve block group

EXPERIMENTAL

Patients will receive lateral femoral cutaneous nerve.

Drug: Lateral femoral cutaneous nerve block

Interventions

Patients received vastus lateralis nerve block with 5 ml of bupivacaine 0.5%.

Also known as: Bupivacaine 0.5%
Vastus lateralis nerve block group

Patients received lateral femoral cutaneous nerve block with 5 ml of bupivacaine 0.5%.

Also known as: Bupivacaine 0.5%
Lateral femoral cutaneous nerve block group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status from I to III.
  • Underwent knee surgeries under spinal anesthesia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 5, 2025

Study Start

February 5, 2025

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations