Clinical trial NCT06293404: The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia
Official title: The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures
Spinal Anesthesia
Keywords: position effect
hip fracture
spinal anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effect of two different positions on spinal anesthesia in hip fracture surgery

Detailed description: One of the more common reasons for hospitalization in affluent nations is femoral fractures. Postpartum mortality and morbidity rates for femur fractures are significant. Mortality rates range from 5% to 8% at the time of initial admission and from 14% to 36% throughout the first year. Age-related mortality rates are rising. Surgery is necessary for femur fractures, and spinal anesthesia is frequently the recommended anaesthetic approach.

After spinal anesthesia, hypotension is frequently seen as a result of sympathetic block and a reduction in systemic vascular resistance. The frequency of hypotension rises as the level of spinal anesthetic block increases, especially in older people. It has been demonstrated that hypotension is connected with an increased mortality rate.

Preoperative fluid administration to reduce hypotension loading, lateral decubitus anesthesia posture, and spinal anesthetic dose reduction techniques have all been used.

There are several methods to enhance the quality of the block in spinal anesthesia, including local changes to the anesthetic's baricity, volume, infusion rate, and lateral decubitus position. There are numerous variables, including residency time and spinal needle type. The influence of alterations in the spinal cord inside the vertebral column on body position in the literature was examined using lumbar MR imaging. Based on these research, it was intended to study the role that alterations in spinal anesthesia played in the applications of spinal anesthesia. spinal column Hemiblock is thought to result in more stable hemodynamics during anesthesia. Studies can be found. The goal of this study is to administer semispinal anesthesia while doing spinal anesthesia. To ensure that the underlying spinal cord is impacted by the local anesthetic and to monitor the impact on unilateral block development and hemodynamic parameters, the colon is flexed and squeezed to the surgery side and anterior area of the spinal cord.

The study will take unilateral femoral fracture surgery into account. Both groups will be given spinal anesthesia in the study's lateral

First, Group F will keep the spinal cord flexed for 10 minutes while Group N will preserve the spinal cord's normal position in lateral decubitus. The quality of the ensuing block will be compared between the two groups. When spinal anesthetic is being used, patients may feel excruciating pain while in the prescribed position.

To lessen positional pain and the impact of hemodynamic deterioration brought on by pain during spinal anesthesia, pericapsular nerve group (PENG) block will be used.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2-3
* Hip fracture
* 18-85 Age
* BMI: 18-40

Exclusion Criteria:

* ASA score of 4 and above
* Left ventricular ejection fraction below 40%
* Severe aortic valve stenosis
* Obesity (BMI \>40)
* Presence of cardiac arrhythmia
* Having peripheral vascular disease
* Failure of spinal block
* Bleeding diathesis

Primary outcomes:
measure: Hemodynamic change
timeFrame: Within 3 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 5 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 10 minutes after anesthesia
measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
timeFrame: 15 minutes
measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
timeFrame: 20 minutes after anesthesia
measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
timeFrame: 30 minutes after anesthesia
Secondary outcomes:
measure: To compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of bupivacaine 7.5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower
timeFrame: 10 minutes after anesthesia
Other outcomes:
measure: To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level
timeFrame: Within 1 minutes after anesthesia
Locations:
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Mehmet Sahap
role: STUDY_DIRECTOR
References: