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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 mg Bupivacaine + Neutral Position | Active Comparator | Participants will receive 8 mg of 0.5% hyperbaric bupivacaine via spinal anesthesia at L3-4 or L4-5 interspace in sitting position. Immediately after injection, participants will be positioned supine in neutral (horizontal, 0°) position and maintained in this position throughout the procedure. Standard hemodynamic monitoring and management protocols will be applied. |
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| 8 mg Bupivacaine + 10° Trendelenburg | Experimental | Participants will receive 8 mg of 0.5% hyperbaric bupivacaine via spinal anesthesia at L3-4 or L4-5 interspace in sitting position. Immediately after injection, participants will be positioned in 10° Trendelenburg position (head-down tilt) and maintained in this position throughout the procedure. Standard hemodynamic monitoring and management protocols will be applied. |
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| 12 mg Bupivacaine + Neutral Position | Active Comparator | Participants will receive 12 mg of 0.5% hyperbaric bupivacaine via spinal anesthesia at L3-4 or L4-5 interspace in sitting position. Immediately after injection, participants will be positioned supine in neutral (horizontal, 0°) position and maintained in this position throughout the procedure. Standard hemodynamic monitoring and management protocols will be applied. |
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| 12 mg Bupivacaine + 10° Trendelenburg | Experimental | Participants will receive 12 mg of 0.5% hyperbaric bupivacaine via spinal anesthesia at L3-4 or L4-5 interspace in sitting position. Immediately after injection, participants will be positioned in 10° Trendelenburg position (head-down tilt) and maintained in this position throughout the procedure. Standard hemodynamic monitoring and management protocols will be applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine %0.5 (hyperbaric) | Drug | 8 mg or 12 mg 0.5% hyperbaric bupivacaine administered intrathecally via spinal anesthesia at L3-4 or L4-5 interspace. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | From injection to 30 minutes post-spinal anesthesia |
| Incidence of Hypotension | Proportion of participants experiencing hypotension, defined as mean arterial pressure (MAP) decrease ≥20% from baseline | From spinal injection through end of surgery |
| 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. | From spinal injection through end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From spinal injection through end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasan Duman, M.D. | Contact | +905547317716 | hasanduman.1991@gmail.com |
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The outcomes assessor evaluating sensory block levels, motor block, and recording data will be blinded to group allocation. The anesthesiologist performing the spinal anesthesia and positioning cannot be blinded due to the nature of the intervention.
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| 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). |
| Throughout surgery |
| Incidence of Bradycardia | Proportion of participants experiencing bradycardia, defined as heart rate <50 beats per minute requiring treatment. | From spinal injection through end of surgery |
| Incidence of Nausea and Vomiting | Proportion of participants experiencing nausea and/or vomiting during the intraoperative and immediate postoperative period. | From spinal injection through end of surgery |