Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

Bursa Yuksek Ihtisas Training and Research Hospital

Status: Completed

Conditions: Femoral Neck Fractures; Regional Anesthesia

Treatments: Procedure: lumbar plexus block; Procedure: hypobaric spinal anaesthesia; Procedure: hyperbaric spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06224439

2023-5/15

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

hypobaric spinal anaesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: hypobaric spinal anaesthesia

lumbar plexus block

Active Comparator group

Description:

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.

Treatment:

Procedure: lumbar plexus block

hyperbaric spinal anaesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: hyperbaric spinal anesthesia