Spinal Anaesthesia Success in Patients With Previous Lumbar Spine Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCelal Kaya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
spinal anesthesia
Procedure/SurgerySingle-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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Prior Lumbar Surgery Group1 intervention
Group B: Control Group Without Prior Lumbar Surgery1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During the spinal anaesthesia procedure, on the day of surgery.Secondary outcomes
1
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.
Time frame
From the first needle insertion until completion or abandonment of the spinal anaesthesia procedure, on the day of surgery.2
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.
Time frame
During the spinal anaesthesia procedure, on the day of surgery.3
Time to Maximum Sensory Block Level
Time in minutes from completion of intrathecal injection to the first observation of the maximum sensory block level.
Time frame
Following intrathecal injection, on the day of surgery.4
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
Time frame
Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Celal Kaya
Lead sponsor
Taksim Egitim ve Arastirma Hastanesi
Sponsor institution
Source ClinicalTrials.gov