The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fractures; Spinal Anesthesia
• Intervention / Treatment: Drug: Bupivacain

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aziz Aysel, MD; Phone Number: 5336826254; Email: dr.azizaysel@gmail.com
• Study Contact Backup: Name: Mehmet Sahap, MD; Email: drsahap@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group F; the lateral decubitus position, Group F will keep the spinal cord flexed for 10 minutes,	Drug: Bupivacain; 7.5 mg Bupivacaine hydrochloride (0.5% heavy Marcaine) will be used on spinal anesthesia. (each group)
Other: Group N; the lateral decubitus position, Group N will keep the natural position of the spinal cord in lateral decubitus for 10 minutes,	Drug: Bupivacain; 7.5 mg Bupivacaine hydrochloride (0.5% heavy Marcaine) will be used on spinal anesthesia. (each group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic change	Heart rate	Within 5 minutes after anesthesia
Hemodynamic change	Heart rate	Within 10 minutes after anesthesia
Hemodynamic change	Heart rate	Within 3 minutes after anesthesia
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.	Heart rate	15 minutes
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.	Heart rate	20 minutes after anesthesia
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.	Heart rate	30 minutes after anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Director: Mehmet Sahap, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: spinal anesthesia; hip fracture; position effect
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: column flexion; AnkaraCHBilkent (Other Identifier: Başkent University Medical School Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No