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Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06224439
Enrollment
300
Registered
2024-01-25
Start date
2024-01-25
Completion date
2025-04-13
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fractures, Regional Anesthesia

Brief 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.

Interventions

PROCEDUREhypobaric 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.

ultrasound and nerve stimulator will be used for lumbar plexus block

PROCEDUREhyperbaric 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.

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
intraoperative haemodynamic parametersintraoperative 2 hoursnon-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg)

Secondary

MeasureTime frameDescription
Entropyintraoperative 2 hoursEntropy 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.
SPIintraoperative 2 hoursThe 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
sedation and analgesicintraoperative 2 hoursIntraoperative sedation and analgesic need (Whether there was a need or not how much is given in total mg or mcg)
Intraoperative bleedingintraoperative 2 hours

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026