Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

Regional Anesthesia Clinical Trial

Official title:

Comparison of the Effectiveness of Lumbar Plexus Block and Hypobaric Unilateral Spinal Anaesthesia in Patients Undergoing Femoral Neck Fracture Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06224439
• Other study ID #: 2023-5/15
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: December 13, 2024

Study information

• Verified date: January 2024
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Korgün Ökmen, Assoc. PhD.
• Phone: +905057081021
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 13, 2024
• Est. primary completion date: October 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Regional Anesthesia

Intervention

Procedure:
• 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.
• lumbar plexus block
ultrasound and nerve stimulator will be used for lumbar plexus block

Locations

Country	Name	City	State
Turkey	Bursa Yuksek Ihtisas Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative haemodynamic parameters	non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg)	intraoperative 2 hours
Secondary	Entropy	Entropy monitoring involves using electroencephalography-a strip of electrodes applied to the forehead-to assess the depth of general anesthesia in surgical patients. The goal of entropy monitoring is to ensure that patients are given appropriate levels of anesthesia so that recovery is faster. Entropy monitoring provides quantitative measurement of depth of anaesthesia. The Response Entropy scale ranges from 0 (no brain activity) to 100 (fully awake) and the State Entropy scale ranges from 0 (no brain activity) to 91 (fully awake). The clinically relevant target range for entropy values is 40-60.	intraoperative 2 hours
Secondary	SPI	The surgical pleth index (SPI) is a dimensionless score which is based on the photoplethysmographic analysis of the pulse wave and the heart beat interval. SPI scores monitored during surgery may reflect a patient's autonomic response to certain nociceptive stimuli. The values of the SPI range from 0 to 100. During general anaesthesia, maintaining a value between 20 and 50 is generally recommended	intraoperative 2 hours
Secondary	sedation and analgesic	Intraoperative sedation and analgesic need (Whether there was a need or not how much is given in total mg or mcg)	intraoperative 2 hours
Secondary	Intraoperative bleeding		intraoperative 2 hours