Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

NCT ID: NCT06224439

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2025-04-13

Brief Summary

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Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge.

Central and peripheral regional anaesthesia methods have advantages and disadvantages. This situation causes difficulties in the choice of anaesthesia method. Central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. The disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners.

Since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.

Detailed Description

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Conditions

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Femoral Neck Fractures Regional Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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hypobaric spinal anaesthesia

25 gauge quincke needle will be used for spinal anaesthesia. After the lateral position is given to the patient with the side to be operated on, the patient will be entered through the appropriate interval (L3-4 or L4-5) to apply hypobaric spinal anaesthesia, and after the feeling of falling in the subdural area is obtained, Cerebro Spinal Fluid arrival will be seen and the drug consisting of 0.5% Bupivacain and distilled water with bupivacaine hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

Group Type ACTIVE_COMPARATOR

hypobaric spinal anaesthesia

Intervention Type PROCEDURE

0.5% Bupivacain and distilled water with bupivacaine hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

lumbar plexus block

A 10-15 cm peripheral block needle, ultrasound and nerve stimulator will be used for lumbar plexus block. Buvicaine with 0.5% Bupivacaine Hydrochloride active substance will be used. It will be diluted half and half with saline. It will be applied in accordance with the patient's height and weight, not exceeding 2mg/kg.

Group Type ACTIVE_COMPARATOR

lumbar plexus block

Intervention Type PROCEDURE

ultrasound and nerve stimulator will be used for lumbar plexus block

hyperbaric spinal anaesthesia

25 gauge quincke needle will be used for spinal anaesthesia. After the lateral position is given to the patient with the side to be operated on, the patient will be entered through the appropriate interval (L3-4 or L4-5) to apply hypobaric spinal anaesthesia, and after the feeling of falling in the subdural area is obtained, Cerebro Spinal Fluid arrival will be seen and the drug consisting of 0.5% hyper Bupivacain hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

Group Type ACTIVE_COMPARATOR

hyperbaric spinal anesthesia

Intervention Type PROCEDURE

0.5% hyperbaric Bupivacain hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

Interventions

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hypobaric spinal anaesthesia

0.5% Bupivacain and distilled water with bupivacaine hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

Intervention Type PROCEDURE

lumbar plexus block

ultrasound and nerve stimulator will be used for lumbar plexus block

Intervention Type PROCEDURE

hyperbaric spinal anesthesia

0.5% hyperbaric Bupivacain hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Korgün Ökmen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023-5/15

Identifier Type: -

Identifier Source: org_study_id

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