NCT06321718

Brief Summary

This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

February 21, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

February 21, 2024

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • recording time for "return of full muscle power"

    duration between the end of surgery and the first time the patient was able to move his operated leg. The full power return will be defined as pre-operative muscle power according to manual muscle testing scale (MRC)/ Muscle Power Scale as following: Score Description 0 No contraction 1. Flicker or trace of contraction 2. Active movement, with gravity eliminated 3. Active movement against gravity 4. Active movement against gravity and resistance 5. Normal power

    at hour 0, 2 hours, 4 hours, 6 hours, 12 hours after procedure

Secondary Outcomes (4)

  • • The degree of hip flexion on the operative side

    at 6 hours, 24 hours, and 48 hours.

  • • Static and dynamic pain scores.

    at 6 hours, 24 hours, and 48 hours.

  • postoperative nausea and vomiting (PONV) scale

    at 48 hours.

  • • The number of rescue analgesia

    24 hours

Study Arms (2)

1. Group (A)

EXPERIMENTAL

will receive PENG + LFCN block

2. group (B)

EXPERIMENTAL

will receive S-FICB

Interventions

1\. Group (A) will receive PENG + LFCN block:

Eligibility Criteria

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

You may qualify if:

  • All hip trauma patients ≥ 18 years' old
  • ASA class I, II, and III
  • Solitary hip fracture

You may not qualify if:

  • Neurological disturbance either baseline or traumatic brain injury
  • Contraindications for regional anesthesia as bleeding disorders, infection at site of injection, or hypersensitivity to the used local anesthetics.
  • Patient refusal.
  • Massive poly trauma.
  • Uncooperative patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university, faculty of medicine

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Through website computer program randomization program to distribute cases into two groups using their order number
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 96 Patients will be enrolled. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. 2 groups well be assessed 1. Group (A) will receive PENG + LFCN block 2. The second group (B): S-FICB
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 20, 2024

Study Start

May 1, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations