Spinal SurgeryNCT07852767
Spinal Anaesthesia Success in Patients With Previous Lumbar Spine Surgery
An observational study of Spinal Surgery and Spinal Aneshtesia, run by Celal Kaya at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare spinal anaesthesia success in adults with and without previous lower back surgery. The main question it aims to answer is: Does previous lower back surgery affect the success of spinal anaesthesia on the first needle insertion? Participants will receive spinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Surgery, Spinal Aneshtesia
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older with ASA physical status I-III who are scheduled to receive spinal anaesthesia as part of routine surgical care at Taksim Training and Research Hospital, Istanbul, Turkey. The study population will include patients with previous lumbar spine surgery and a comparison cohort without previous lumbar spine surgery.
Who may be able to join
- Age 18 years or older.
- American Society of Anaesthesiologists (ASA) physical status classification I-III.
- Scheduled to receive clinically indicated spinal anaesthesia for surgery, performed by clinicians other than the researchers collecting study data.
- Provision of written informed consent.
Who cannot join
- Any clinical contraindication to spinal anaesthesia.
- Refusal to participate or inability to provide written informed consent.
- Severe cognitive impairment preventing study assessments.
- Planned epidural or combined spinal-epidural anaesthesia.
- Inability to reliably record study data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Taksim Training and Research Hospital
Istanbul
celal kaya, 905435176760, c.kaya47@hotmail.com
Sena Yildiz, MD, 905372630427, dr.senayildiz@hotmail.com
About this study
The goal of this observational study is to compare spinal anaesthesia success in adults with and without previous lower back surgery. The main question it aims to answer is:
- Does previous lower back surgery affect the success of spinal anaesthesia on the first needle insertion?
Participants will receive spinal anaesthesia as part of their usual medical care. Researchers will record needle attempts, procedure time, and anaesthesia effectiveness. Participation will not involve additional procedures or changes to routine care.
Read the detailed description
Previous lumbar spine surgery can alter anatomical landmarks and produce scar tissue that may make spinal anaesthesia technically more difficult. This study will examine the association between prior lumbar surgery and technical performance during routine spinal anaesthesia.
Patients will be grouped according to whether they have a history of lumbar spine surgery. Anaesthesia decisions will be made by treating clinicians who are not involved in research data collection. No anaesthetic technique or treatment will be assigned by the researchers.
Demographic and clinical characteristics, previous lumbar surgery details, and procedural observations will be collected prospectively using a standardized form. This will allow technical difficulties to be examined alongside block characteristics and early hemodynamic changes.
An internal pilot phase will include 25 patients in each group. Pilot estimates of first-insertion success will inform the sample size calculation for the main study. Group-specific success rates and their absolute difference will be reported with 95% confidence intervals.
- Conditions
- Spinal Surgery, Spinal Aneshtesia
- Being tested
- spinal anesthesia
- Keywords
- Previous lumbar spine surgery, Neuraxial anesthesia, Spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
Single-shot spinal anaesthesia administered as part of routine surgical care in patients with or without previous lumbar spine surgery. The treating anaesthesiologist will determine the puncture site, needle type, approach, and anaesthetic drug and dose according to clinical judgment. Researchers will not assign or modify the procedure and will only collect observational data.
| Study group | Role | What they receive |
|---|---|---|
| Prior Lumbar Surgery Group | Adults with a history of lumbar spine surgery who are scheduled to receive spinal anaesthesia as part of routine care for another surgical procedure. Receives: Procedure: spinal anesthesia | |
| Control Group Without Prior Lumbar Surgery | Adults without a history of lumbar spine surgery who are scheduled to receive spinal anaesthesia as part of routine surgical care. This cohort will serve as the comparison group. Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Anaesthesia Success on the First Needle Insertion
Percentage of patients in whom spinal anaesthesia is successfully performed on the first needle insertion, compared between patients with and without previous lumbar spine surgery.
Measured: During the spinal anaesthesia procedure, on the day of surgery.
Secondary outcomes (5)
Total Number of Skin Punctures
Total number of separate skin punctures made during the spinal anaesthesia procedure, compared between patients with and without previous lumbar spine surgery. Each needle insertion through the skin counts as a new puncture.
Measured: From the first needle insertion until completion or abandonment of the spinal anaesthesia procedure, on the day of surgery.
Spinal Anaesthesia Procedure Duration
Time in seconds after back covered to completion of intrathecal injection. For unsuccessful procedures, time until abandonment will be recorded separately.
Measured: During the spinal anaesthesia procedure, on the day of surgery.
Time to Maximum Sensory Block Level
Time in minutes from completion of intrathecal injection to the first observation of the maximum sensory block level.
Measured: Following intrathecal injection, on the day of surgery.
Blood Pressure Changes
Changes in systolic and diastolic blood pressure, measured in mmHg, from the pre-spinal baseline during the first 30 minutes after spinal anaesthesia
Measured: Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.
Heart Rate Changes
Changes in heart rate, measured in beats per minute, from the pre-spinal baseline during the first 30 minutes after spinal anaesthesia.
Measured: Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026
- Primary completion28 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Celal Kaya
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Celal Kaya, Taksim Egitim ve Arastirma Hastanesi
- Investigators
- Celal Kaya, Principal investigator, Taksim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852767
- Sponsor's protocol ID
- E-62190176-663.05-329411125
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Under the study protocol, access to participant-level data is restricted to the research team. Findings will be disseminated through publications and presentations using aggregate results.
Publications
Zhu G, Wang X, Yang L. Real-time ultrasound-guided neuraxial anesthesia for cesarean section in parturients with previous internal fixation surgery for lumbar fracture: a case series. Quant Imaging Med Surg. 2023 Jan 1;13(1):529-535. doi: 10.21037/qims-22-223. Epub 2022 Oct 26. No abstract available.
PubMed 36620151Kim SH, Jeon DH, Chang CH, Lee SJ, Shin YS. Spinal anesthesia with isobaric tetracaine in patients with previous lumbar spinal surgery. Yonsei Med J. 2009 Apr 30;50(2):252-6. doi: 10.3349/ymj.2009.50.2.252.
PubMed 19430559Hebl JR, Horlocker TT, Kopp SL, Schroeder DR. Neuraxial blockade in patients with preexisting spinal stenosis, lumbar disk disease, or prior spine surgery: efficacy and neurologic complications. Anesth Analg. 2010 Dec;111(6):1511-9. doi: 10.1213/ANE.0b013e3181f71234. Epub 2010 Sep 22.
PubMed 20861423
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anaesthesia Success in Patients With Previous Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT07852767
- Acronym / sponsor ID
- E-62190176-663.05-329411125
- Conditions
- Spinal Surgery, Spinal Aneshtesia
- Keywords
- Previous lumbar spine surgery, Neuraxial anesthesia, Spinal anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Celal KayaOther government
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2026 (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 goal of this observational study is to compare spinal anaesthesia success in adults with and without previous lower back surgery. The main question it aims to answer is:
- Does previous lower back surgery affect the success of spinal anaesthesia on the first needle insertion?
Participants will receive spinal anaesthesia as part of their usual medical care. Researchers will record needle attempts, procedure time, and anaesthesia effectiveness. Participation will not involve additional procedures or changes to routine care.
Detailed description
Previous lumbar spine surgery can alter anatomical landmarks and produce scar tissue that may make spinal anaesthesia technically more difficult. This study will examine the association between prior lumbar surgery and technical performance during routine spinal anaesthesia.
Patients will be grouped according to whether they have a history of lumbar spine surgery. Anaesthesia decisions will be made by treating clinicians who are not involved in research data collection. No anaesthetic technique or treatment will be assigned by the researchers.
Demographic and clinical characteristics, previous lumbar surgery details, and procedural observations will be collected prospectively using a standardized form. This will allow technical difficulties to be examined alongside block characteristics and early hemodynamic changes.
An internal pilot phase will include 25 patients in each group. Pilot estimates of first-insertion success will inform the sample size calculation for the main study. Group-specific success rates and their absolute difference will be reported with 95% confidence intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior Lumbar Surgery Group | – | Procedure: spinal anesthesiaAdults with a history of lumbar spine surgery who are scheduled to receive spinal anaesthesia as part of routine care for another surgical procedure. |
| Control Group Without Prior Lumbar Surgery | – | Procedure: spinal anesthesiaAdults without a history of lumbar spine surgery who are scheduled to receive spinal anaesthesia as part of routine surgical care. This cohort will serve as the comparison group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older with ASA physical status I-III who are scheduled to receive spinal anaesthesia as part of routine surgical care at Taksim Training and Research Hospital, Istanbul, Turkey. The study population will include patients with previous lumbar spine surgery and a comparison cohort without previous lumbar spine surgery.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- American Society of Anaesthesiologists (ASA) physical status classification I-III.
- Scheduled to receive clinically indicated spinal anaesthesia for surgery, performed by clinicians other than the researchers collecting study data.
- Provision of written informed consent.
Key exclusion criteria (5 listed)
- Any clinical contraindication to spinal anaesthesia.
- Refusal to participate or inability to provide written informed consent.
- Severe cognitive impairment preventing study assessments.
- Planned epidural or combined spinal-epidural anaesthesia.
- Inability to reliably record study data.
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 |
|---|---|---|
| spinal anesthesiaSingle-shot spinal anaesthesia administered as part of routine surgical care in patients with or without previous lumbar spine surgery. The treating anaesthesiologist will determine the puncture site, needle type, approach, and anaesthetic drug and dose according to clinical judgment. Researchers will not assign or modify the procedure and will only collect observational data. | Procedure or surgery | Control Group Without Prior Lumbar Surgery, Prior Lumbar Surgery Group |
Primary outcome
Spinal Anaesthesia Success on the First Needle Insertion
Time frame: During the spinal anaesthesia procedure, on the day of surgery.
Percentage of patients in whom spinal anaesthesia is successfully performed on the first needle insertion, compared between patients with and without previous lumbar spine surgery.
5 secondary outcomes
Total Number of Skin Punctures
Time frame: From the first needle insertion until completion or abandonment of the spinal anaesthesia procedure, on the day of surgery.
Spinal Anaesthesia Procedure Duration
Time frame: During the spinal anaesthesia procedure, on the day of surgery.
Time to Maximum Sensory Block Level
Time frame: Following intrathecal injection, on the day of surgery.
Blood Pressure Changes
Time frame: Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.
Heart Rate Changes
Time frame: Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 36620151Zhu G, Wang X, Yang L. Real-time ultrasound-guided neuraxial anesthesia for cesarean section in parturients with previous internal fixation surgery for lumbar fracture: a case series. Quant Imaging Med Surg. 2023 Jan 1;13(1):529-535. doi: 10.21037/qims-22-223. Epub 2022 Oct 26. No abstract available.
- Results publication: PubMed 19430559Kim SH, Jeon DH, Chang CH, Lee SJ, Shin YS. Spinal anesthesia with isobaric tetracaine in patients with previous lumbar spinal surgery. Yonsei Med J. 2009 Apr 30;50(2):252-6. doi: 10.3349/ymj.2009.50.2.252.
- Results publication: PubMed 20861423Hebl JR, Horlocker TT, Kopp SL, Schroeder DR. Neuraxial blockade in patients with preexisting spinal stenosis, lumbar disk disease, or prior spine surgery: efficacy and neurologic complications. Anesth Analg. 2010 Dec;111(6):1511-9. doi: 10.1213/ANE.0b013e3181f71234. Epub 2010 Sep 22.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Under the study protocol, access to participant-level data is restricted to the research team. Findings will be disseminated through publications and presentations using aggregate results.
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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.
Celal Kaya principal investigator
Taksim Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Surgery and Spinal Aneshtesia, run by Celal Kaya at 1 site in Turkey (Türkiye).
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 5 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celal Kaya, MD (905435176760, c.kaya47@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Anaesthesia Success on the First Needle Insertion (time frame: During the spinal anaesthesia procedure, on the day of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852767, which also lists 3 linked publications.
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 6 Oct 2026.