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NCT Number: NCT06293404

The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain

Drug

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

Primary outcomes

  1. Hemodynamic change

    Time frame: Within 3 minutes after anesthesia

    Heart rate

  2. Hemodynamic change

    Time frame: Within 5 minutes after anesthesia

    Heart rate

  3. Hemodynamic change

    Time frame: Within 10 minutes after anesthesia

    Heart rate

  4. Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.

    Time frame: 15 minutes

    Heart rate

  5. Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.

    Time frame: 20 minutes after anesthesia

    Heart rate

  6. Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.

    Time frame: 30 minutes after anesthesia

    Heart rate

Secondary outcomes

  1. 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

    Time frame: 10 minutes after anesthesia

    bromage score

Other outcomes

  1. To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level

    Time frame: Within 1 minutes after anesthesia

    sensory block time

Study contacts

Contact information is provided by the study sponsor or research team.

Aziz Aysel, MD

CONTACT

[email protected]

5336826254

Mehmet Sahap, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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