Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypobaric spinal anaesthesia | Active Comparator | 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. |
|
| lumbar plexus block | Active Comparator | 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. |
|
| hyperbaric spinal anaesthesia | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypobaric spinal anaesthesia | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative haemodynamic parameters | non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg) | intraoperative 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Yuksek Ihtisas Training and Research Hospital | Bursa | 16110 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| lumbar plexus block | Procedure | ultrasound and nerve stimulator will be used for lumbar plexus block |
|
| hyperbaric spinal anesthesia | 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. |
|
| intraoperative 2 hours |
| 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 |
| 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 |
| Intraoperative bleeding | intraoperative 2 hours |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |