Spinal AnesthesiaNCT07376798
Effect of Patient Position on Bupivacaine Dose Requirement and Hemodynamic Stability in Spinal Anesthesia
A study testing Bupivacaine %0.5 (hyperbaric) in people with Spinal Anesthesia and Hemodynamic Changes, run by University of Health Sciences Balikesir Hospital Eduation and Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Anesthesia, Hemodynamic Changes, Patient Positions
- What is being tested?
- Bupivacaine %0.5 (hyperbaric)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy
- Psychiatric illness preventing effective communication
- Refusal to participate in the study
- Unable to understand or provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read more
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.
- Conditions
- Spinal Anesthesia, Hemodynamic Changes, Patient Positions, Bupivacaine
- Being tested
- Bupivacaine %0.5 (hyperbaric)
- Keywords
- Spinal Anesthesia, Bupivacaine, Patient Positioning, hemodynamic changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Bupivacaine %0.5 (hyperbaric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: From spinal injection through end of surgery
Secondary outcomes (4)
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).
Measured: From spinal injection through end of surgery
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).
Measured: Throughout surgery
Incidence of Bradycardia
Proportion of participants experiencing bradycardia, defined as heart rate <50 beats per minute requiring treatment.
Measured: 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.
Measured: From spinal injection through end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376798
- Sponsor's protocol ID
- hduman
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Position on Bupivacaine Dose Requirement and Hemodynamic Stability in Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07376798
- Acronym / sponsor ID
- hduman
- Conditions
- Spinal Anesthesia, Hemodynamic Changes, Patient Positions, Bupivacaine
- Keywords
- Spinal Anesthesia, Bupivacaine, Patient Positioning, hemodynamic changes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and ResearchOther government
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 8 mg Bupivacaine + Neutral Position | Active comparator | Drug: Bupivacaine %0.5 (hyperbaric)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. |
| 8 mg Bupivacaine + 10° Trendelenburg | Experimental | Drug: Bupivacaine %0.5 (hyperbaric)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. |
| 12 mg Bupivacaine + Neutral Position | Active comparator | Drug: Bupivacaine %0.5 (hyperbaric)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. |
| 12 mg Bupivacaine + 10° Trendelenburg | Experimental | Drug: Bupivacaine %0.5 (hyperbaric)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | 12 mg Bupivacaine + 10° Trendelenburg, 12 mg Bupivacaine + Neutral Position, 8 mg Bupivacaine + 10° Trendelenburg, 8 mg Bupivacaine + Neutral Position |
Primary outcome
Maximum Sensory Block Level
Time frame: From injection to 30 minutes post-spinal anesthesia
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
Time frame: From spinal injection through end of surgery
Proportion of participants experiencing hypotension, defined as mean arterial pressure (MAP) decrease ≥20% from baseline
Sensory Block Onset Time
Time frame: From spinal injection through end of surgery
Time required to achieve T10 dermatomal sensory block level, measured from completion of intrathecal injection to confirmation of T10 level by pin-prick test.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine %0.5 (hyperbaric) in people with Spinal Anesthesia and Hemodynamic Changes, run by University of Health Sciences Balikesir Hospital Eduation and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan Duman, M.D. (+905547317716, hasanduman.1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Sensory Block Level (time frame: From injection to 30 minutes post-spinal anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.