NCT06990958

Brief Summary

This clinical study compares two types of nerve blocks used to control pain in adult patients undergoing surgery on the upper (proximal) or middle (midshaft) part of the femur (thigh bone). The two blocks being studied are the Erector Spinae Plane (ESP) block and the Fascia Iliaca Compartment (FIC) block. Both techniques are commonly used in hospitals to reduce postoperative pain. The goal is to determine which nerve block provides more effective pain relief, reduces the need for opioid medications, and supports faster recovery in patients following femur surgery. Results from this study may improve pain management strategies for similar procedures in the future. Adults scheduled for proximal or midshaft femur surgery may be eligible to participate. Eligibility is determined based on clinical criteria reviewed by the study team.Administration of one of the two nerve blocks before surgery.Standard surgical and postoperative care. Monitoring of pain levels at specific time points after surgery Recording of opioid medication usage Evaluation of patient satisfaction and any side effects related to the nerve block Duration: The intervention (nerve block) is administered once before surgery. Data collection continues during the immediate postoperative period and for a short time following surgery to assess outcomes. Both nerve blocks are considered safe and are regularly used in clinical practice. All procedures are performed by qualified clinicians, and safety monitoring is conducted throughout the study. Participants may experience improved pain relief and reduced need for opioid medications. While direct benefit cannot be guaranteed, information gained from the study may help improve pain management for future patients undergoing similar surgeries. Participation in the study is completely voluntary. Patients may choose not to participate or may withdraw from the study at any time without affecting the quality of their medical care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

May 18, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

Fascia iliac block, erector spinae block, femur fracture, adult analgesia

Outcome Measures

Primary Outcomes (1)

  • duration of the block

    time starting immediatelyafter giving the block till the first postoperative analgesic rescue which will be used if the pain score exceeds 4/10

    15 minutes after extubation till 24 hours postoperative

Study Arms (2)

ESPB Group

ACTIVE COMPARATOR

patients was placed in the lateral position . the block was performed bz ipsilateral injection of a mixture containing 15mls bupivcaine 0,5% and 20mls normal saline.

Procedure: Erector Spinae Plane Block (ESPB) group

FICB

ACTIVE COMPARATOR

Patients was placed insupine position . the block performed using a mixture of 15mls bupivcaine 0,5% and 20mls normal saline.

Procedure: Fascia iliaca compartment block (FICB)

Interventions

ultrasound guided erector spinae plane block (at lumbar level) in lateral position .

ESPB Group

ultrasound guided suprainguinal approach in supine position

FICB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-80
  • American society of Anathesiologist physical status ASA Ior II
  • Patients undergoing Fixation of femur fractures

You may not qualify if:

  • Refusal of participation in study.
  • Bleeding disorders (platelets count \< 80,000, INR \>1.5, Prothrombin concentration \< 60%).
  • Skin lesion, wounds or infection at the puncture site. Known allergy to local anesthetic drugs.
  • Known local anesthetic (LA) drug sensitivity. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr alainy hospital -Cairo university , cairo

Cairo, Egypt

Location

MeSH Terms

Conditions

Femoral FracturesAgnosia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, surgical ICU and Pain Management Faculty of Medicine, Cairo University

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 25, 2025

Study Start

March 5, 2025

Primary Completion

July 10, 2025

Study Completion

August 10, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations