NCT06852378

Brief Summary

This study aims to compare iliopsoas nerve Block (IPB) to femoral nerve block (FNB) regarding pain control, patient satisfaction, and early ambulation in patients undergoing hip fracture surgeries

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 all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

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

February 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

February 25, 2025

Last Update Submit

March 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of pain

    Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed upon arrival at the post-anesthesia care unit (PACU) and at 2, 4, 6,12, 24 post-surgery.

    24 hours postoperatively

Secondary Outcomes (5)

  • Total opioids consumption

    24 hours postoperatively

  • Assessment of quadriceps strength

    24 hours postoperatively

  • Time of ambulation

    24 hours postoperatively

  • Patients' satisfaction

    24 hours postoperatively

  • Incidence of complications

    24 hours postoperatively

Study Arms (2)

Iliopsoas nerve block group

Patients will receive an Iliopsoas nerve block using 10 ml of bupivacaine 0.5%.

Drug: Iliopsoas nerve block

Femoral nerve block group

Patients will receive femoral nerve block using 10 ml of bupivacaine 0.5%.

Drug: Femoral nerve block

Interventions

Patients will receive an Iliopsoas nerve block using 10 ml of bupivacaine 0.5%.

Also known as: Bupivacaine 0.5%
Iliopsoas nerve block group

Patients will receive femoral nerve block using 10 ml of bupivacaine 0.5%.

Also known as: Bupivacaine 0.5%
Femoral nerve block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This prospective, single-blind cohort study will be conducted on 80 patients scheduled for elective surgical correction of hip fracture after obtaining approval from the Research Ethical Committee of Ain Shams University. It will be conducted in the assembled operation rooms in Ain Shams University Hospitals.

You may qualify if:

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II.
  • Patients who are scheduled for elective surgical correction of hip fracture either through open fracture internal fixation (ORIF), partial hip arthroplasty or total hip arthroplasty.

You may not qualify if:

  • Refusal to participate.
  • Coagulopathy.
  • Patients with a history of drug allergies to study drugs.
  • Inability to cooperate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

Central Study Contacts

Hazem K Saeed, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesia, Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

First Submitted

February 25, 2025

First Posted

February 28, 2025

Study Start

March 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

March 4, 2025

Record last verified: 2025-03

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