NCT07346885

Brief Summary

Femoral neck fracture surgery in elderly patients is frequently complicated by intraoperative hypotension and inadequate postoperative analgesia. Regional anesthesia techniques are increasingly preferred to reduce hemodynamic instability and improve pain control. This prospective observational study aims to compare the efficacy of lumbar and sacral plexus block with fascia iliaca block combined with low-dose spinal anesthesia in terms of severe intraoperative hypotension and postoperative analgesic outcomes in patients undergoing surgery for femoral neck fracture.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress60%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

December 29, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 29, 2025

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Severe Intraoperative Hypotension

    Severe hypotension defined as mean arterial pressure (MAP) \< 65 mmHg lasting longer than 12 minutes during surgery

    Intraoperative period

Secondary Outcomes (6)

  • intraoperative haemodynamic parameters

    intraoperative 2 hours

  • Total Intraoperative Sedative and Analgesic Drug Consumption

    intraoperative 2 hours

  • Estimated Intraoperative Blood Loss (mL)

    intraoperative 2 hours

  • Postoperative Pain Intensity Assessed by the Numeric Rating Scale (NRS)

    postoperative 24 hour

  • Intraoperative Vasopressor Consumption

    Intraoperative period

  • +1 more secondary outcomes

Study Arms (2)

Lumbar and Sacral Plexus Block Group

ACTIVE COMPARATOR

Patients will receive combined lumbar and sacral plexus blocks as the primary regional anesthesia technique for femoral neck fracture surgery, performed by the attending anesthesiologist according to institutional practice.

Procedure: Lumbar and Sacral Plexus Block

Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia Group

ACTIVE COMPARATOR

Patients will receive low-dose spinal anesthesia combined with a supra-inguinal fascia iliaca block for surgical anesthesia and postoperative analgesia.

Procedure: Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia

Interventions

Spinal anesthesia will be administered using a 25-gauge Quincke needle. After positioning the patient on the side to be operated on in a lateral position, hypobaric spinal anesthesia will be administered through an appropriate (L3-4 or L4-5) with 1.5 cc of local anesthetic mixture. Before receiving spinal anesthesia, patients will undergo a supra-inguinal fascia iliaca block with 20 to 30 milliliters of 0.25% local anesthetic (bupivacaine).

Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia Group

For lumbar and sacral plexus blocks, a 10-15 cm ultrasound-visible peripheral nerve block needle and a nerve stimulator will be used. For lumbar plexus shamrock imaging and sacral plexus blocks, parasacral imaging will be used. 0.5% bupivacaine will be used as the local anesthetic.

Lumbar and Sacral Plexus Block Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years and \<90 years
  • American Society of Anesthesiologists score between I and IV
  • Patients who will undergo femoral neck fracture surgery

You may not qualify if:

  • Previous local anesthetic allergy
  • Those with bleeding diathesis disorder
  • Having a mental disorder
  • Those who are allergic to the drugs used
  • Patients who did not consent to participate in the study
  • Presence of infection in the block area
  • Body mass index \>30
  • Preoperative or intraoperative general anesthesia
  • Patients for whom consent cannot be obtained
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 16, 2026

Study Start

December 30, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations