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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06293404
Other study ID # column flexion
Secondary ID AnkaraCHBilkent
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date April 2024

Study information

Verified date February 2024
Source Ankara City Hospital Bilkent
Contact Aziz Aysel, MD
Phone 5336826254
Email dr.azizaysel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacain
7.5 mg Bupivacaine hydrochloride (0.5% heavy Marcaine) will be used on spinal anesthesia. (each group)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Outcome

Type Measure Description Time frame Safety issue
Other To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level sensory block time Within 1 minutes after anesthesia
Primary Hemodynamic change Heart rate Within 3 minutes after anesthesia
Primary Hemodynamic change Heart rate Within 5 minutes after anesthesia
Primary Hemodynamic change Heart rate Within 10 minutes after anesthesia
Primary Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. Heart rate 15 minutes
Primary Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. Heart rate 20 minutes after anesthesia
Primary Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. Heart rate 30 minutes after anesthesia
Secondary 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 bromage score 10 minutes after anesthesia
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