NCT07376798

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

Spinal AnesthesiaHemodynamic ChangesPatient PositionsBupivacaine

Keywords

Spinal AnesthesiaBupivacainePatient Positioninghemodynamic changes

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (4)

  • Motor Block Degree

    From spinal injection through end of surgery

  • Surgical Adequacy

    Throughout surgery

  • Incidence of Bradycardia

    From spinal injection through end of surgery

  • Incidence of Nausea and Vomiting

    From spinal injection through end of surgery

Study Arms (4)

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.

Drug: Bupivacaine %0.5 (hyperbaric)

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.

Drug: Bupivacaine %0.5 (hyperbaric)

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.

Drug: Bupivacaine %0.5 (hyperbaric)

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.

Drug: Bupivacaine %0.5 (hyperbaric)

Interventions

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.

12 mg Bupivacaine + 10° Trendelenburg12 mg Bupivacaine + Neutral Position8 mg Bupivacaine + 10° Trendelenburg8 mg Bupivacaine + Neutral Position

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • American Society of Anesthesiologists (ASA) physical status classification I-II
  • Scheduled for elective urogenital surgery
  • Suitable candidate for spinal anesthesia
  • Able to read, understand, and provide written informed consent
  • Body Mass Index (BMI) less than 35 kg/m²
  • Willing to participate in the study

You may not qualify if:

  • 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)
  • ASA physical status classification III or higher
  • Emergency surgery
  • Pregnancy
  • Psychiatric illness preventing effective communication
  • Refusal to participate in the study
  • Unable to understand or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Hasan Duman, M.D.

CONTACT

+905547317716hasanduman.1991@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

January 30, 2026

Primary Completion

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share