About this trial
This study compares different combinations of local anesthetic doses and patient positions during spinal anesthesia for urogenital surgery. Spinal anesthesia is a common and safe technique where medication is injected into the lower back to numb the body during surgery.
The study will test two different doses of bupivacaine (a numbing medication): a lower dose (8 mg) and a standard dose (12 mg). It will also test two different patient positions after the spinal injection: lying flat (neutral position) and lying with the head slightly lower than the feet (Trendelenburg position).
Participants will be randomly assigned to one of four groups:
* Group 1: Lower dose + lying flat * Group 2: Lower dose + head-down position * Group 3: Standard dose + lying flat * Group 4: Standard dose + head-down position
The study will measure how well the anesthesia works, how high the numbness spreads in the body, and how it affects blood pressure and heart rate. The goal is to find the best combination of dose and position that provides good anesthesia while keeping blood pressure stable.
This research may help doctors choose the safest and most effective anesthesia approach for each patient based on their individual needs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-70 years
American Society of Anesthesiologists (ASA) physical status classification I-II
Scheduled for elective urogenital surgery
Suitable candidate for spinal anesthesia
Disqualifiers
Contraindications to spinal anesthesia (coagulopathy, infection at injection site, patient refusal)
History of neurological disease
Spinal deformity or previous spinal surgery
History of allergic reaction to local anesthetics (amide-type)
Trial design
Factorial
Treatments tested in this trial
Bupivacaine %0.5 (hyperbaric)
Drug8 mg or 12 mg 0.5% hyperbaric bupivacaine administered intrathecally via spinal anesthesia at L3-4 or L4-5 interspace.
Treatment groups
Trial outcomes
Primary outcomes
Maximum Sensory Block Level
The highest dermatomal level of sensory blockade achieved, assessed using pin-prick test (sharp/dull discrimination). Measured as the specific dermatome level (e.g., T4, T6, T8).
Incidence of Hypotension
Proportion of participants experiencing hypotension, defined as mean arterial pressure (MAP) decrease ≥20% from baseline
Sensory Block Onset Time
Time required to achieve T10 dermatomal sensory block level, measured from completion of intrathecal injection to confirmation of T10 level by pin-prick test.
Secondary outcomes
Motor Block Degree
Degree of motor blockade assessed using modified Bromage scale (0=no motor block, able to raise extended leg; 1=unable to raise extended leg, able to flex knee; 2=unable to flex knee, able to flex ankle; 3=complete motor block, unable to move).
Surgical Adequacy
Proportion of participants with adequate anesthesia for surgical procedure completion, assessed as adequate (surgery completed without supplemental analgesia/sedation) or inadequate (requiring supplemental intervention).
Incidence of Bradycardia
Proportion of participants experiencing bradycardia, defined as heart rate \<50 beats per minute requiring treatment.
Incidence of Nausea and Vomiting
Proportion of participants experiencing nausea and/or vomiting during the intraoperative and immediate postoperative period.
Locations
Sponsors and contacts
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