Hip FracturesNCT06293404
The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia
A study testing Bupivacain in people with Hip Fractures and Spinal Anesthesia, run by Ankara City Hospital Bilkent.
Trial summary
The effect of two different positions on spinal anesthesia in hip fracture surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Fractures, Spinal Anesthesia
- What is being tested?
- Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2-3
- Hip fracture
- 18-85 Age
- BMI: 18-40
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Mehmet Sahap, MD contact
About this study
The effect of two different positions on spinal anesthesia in hip fracture surgery
Read the 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
- Being tested
- Bupivacain
- Keywords
- position effect, hip fracture, spinal anesthesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
7.5 mg Bupivacaine hydrochloride (0.5% heavy Marcaine) will be used on spinal anesthesia. (each group)
| Study group | Role | What they receive |
|---|---|---|
| Group F | Active comparator | the lateral decubitus position, Group F will keep the spinal cord flexed for 10 minutes, Receives: Drug: Bupivacain |
| Group N | Other | the lateral decubitus position, Group N will keep the natural position of the spinal cord in lateral decubitus for 10 minutes, Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic change
Heart rate
Measured: Within 3 minutes after anesthesia
Hemodynamic change
Heart rate
Measured: Within 5 minutes after anesthesia
Hemodynamic change
Heart rate
Measured: Within 10 minutes after anesthesia
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
Heart rate
Measured: 15 minutes
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
Heart rate
Measured: 20 minutes after anesthesia
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
Heart rate
Measured: 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
bromage score
Measured: 10 minutes after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Sahap, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293404
- Sponsor's protocol ID
- column flexion
- Other IDs
- AnkaraCHBilkent
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only results
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06293404
- Acronym / sponsor ID
- column flexion
- Conditions
- Hip Fractures, Spinal Anesthesia
- Keywords
- position effect, hip fracture, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | Active comparator | Drug: Bupivacainthe lateral decubitus position, Group F will keep the spinal cord flexed for 10 minutes, |
| Group N | Other | Drug: Bupivacainthe lateral decubitus position, Group N will keep the natural position of the spinal cord in lateral decubitus for 10 minutes, |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1-2-3
- Hip fracture
- 18-85 Age
- BMI: 18-40
Key exclusion criteria (8 listed)
- ASA score of 4 and above
- Left ventricular ejection fraction below 40%
- Severe aortic valve stenosis
- Obesity (BMI >40)
- Presence of cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacain7.5 mg Bupivacaine hydrochloride (0.5% heavy Marcaine) will be used on spinal anesthesia. (each group) | Drug | Group F, Group N |
Primary outcome
Hemodynamic change
Time frame: Within 3 minutes after anesthesia
Heart rate
Hemodynamic change
Time frame: Within 5 minutes after anesthesia
Heart rate
Hemodynamic change
Time frame: Within 10 minutes after anesthesia
Heart rate
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
Time frame: 15 minutes
Heart rate
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
Time frame: 20 minutes after anesthesia
Heart rate
Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.
Time frame: 30 minutes after anesthesia
Heart rate
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No. only results
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
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Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
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Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
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A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Sahap, MD contact
Mehmet Sahap study director
Ankara City Hospital Bilkent
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacain in people with Hip Fractures and Spinal Anesthesia, run by Ankara City Hospital Bilkent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aziz Aysel, MD (5336826254, dr.azizaysel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic change (time frame: Within 3 minutes after anesthesia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.