The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia

NCT ID: NCT06293404

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-12-31

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.

Conditions

Hip Fractures; Spinal Anesthesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group F

the lateral decubitus position, Group F will keep the spinal cord flexed for 10 minutes,

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

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

Group N

the lateral decubitus position, Group N will keep the natural position of the spinal cord in lateral decubitus for 10 minutes,

Group Type: OTHER

Bupivacain

Intervention Type: DRUG

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

Interventions

Bupivacain

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehmet Sahap

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Central Contacts

Aziz Aysel, MD

Role: CONTACT

dr.azizaysel@gmail.com

5336826254

Mehmet Sahap, MD

Role: CONTACT

drsahap@gmail.com

Other Identifiers

AnkaraCHBilkent

Identifier Type: OTHER

Identifier Source: secondary_id

column flexion

Identifier Type: -

Identifier Source: org_study_id