The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
The effect of two different positions on spinal anesthesia in hip fracture surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 31, 2024
July 1, 2024
2 months
January 31, 2024
July 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Hemodynamic change
Heart rate
Within 3 minutes after anesthesia
Hemodynamic change
Heart rate
Within 5 minutes after anesthesia
Hemodynamic change
Heart rate
Within 10 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 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
10 minutes after anesthesia
Other Outcomes (1)
To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level
Within 1 minutes after anesthesia
Study Arms (2)
Group F
ACTIVE COMPARATORthe lateral decubitus position, Group F will keep the spinal cord flexed for 10 minutes,
Group N
OTHERthe lateral decubitus position, Group N will keep the natural position of the spinal cord in lateral decubitus for 10 minutes,
Interventions
7.5 mg Bupivacaine hydrochloride (0.5% heavy Marcaine) will be used on spinal anesthesia. (each group)
Eligibility Criteria
You may qualify if:
- ASA 1-2-3
- Hip fracture
- Age
- BMI: 18-40
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mehmet Sahap
Ankara City Hospital Bilkent
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2024
First Posted
March 5, 2024
Study Start
August 1, 2024
Primary Completion
October 1, 2024
Study Completion
December 1, 2024
Last Updated
July 31, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
only results