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Not yet recruiting NCT07376798

Effect of Patient Position on Bupivacaine Dose Requirement and Hemodynamic Stability in Spinal Anesthesia

No phase Interventional Spinal Anesthesia Hemodynamic Changes Patient Positions Bupivacaine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine %0.5 (hyperbaric).
Who it may be relevant to
Registry conditions: Spinal Anesthesia, Hemodynamic Changes, Patient Positions, Bupivacaine. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Bupivacaine %0.5 (hyperbaric)
    8 mg or 12 mg 0.5% hyperbaric bupivacaine administered intrathecally via spinal anesthesia at L3-4 or L4-5 interspace.

Primary outcome measures

  • Maximum Sensory Block Level [Time frame: From injection to 30 minutes post-spinal anesthesia]
  • Incidence of Hypotension [Time frame: From spinal injection through end of surgery]
  • Sensory Block Onset Time [Time frame: From spinal injection through end of surgery]
Secondary outcome measures (4)
  • Motor Block Degree [Time frame: From spinal injection through end of surgery]
  • Surgical Adequacy [Time frame: Throughout surgery]
  • Incidence of Bradycardia [Time frame: From spinal injection through end of surgery]
  • Incidence of Nausea and Vomiting [Time frame: From spinal injection through end of surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07376798 · hduman

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗