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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Health Sciences Balikesir Hospital Eduation and Research

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: 8 mg Bupivacaine + Neutral PositionActive comparator 1 intervention
Group B: 8 mg Bupivacaine + 10° TrendelenburgExperimental treatment 1 intervention
Group C: 12 mg Bupivacaine + Neutral PositionActive comparator 1 intervention
Group D: 12 mg Bupivacaine + 10° TrendelenburgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From injection to 30 minutes post-spinal anesthesia
2

Incidence of Hypotension

Proportion of participants experiencing hypotension, defined as mean arterial pressure (MAP) decrease ≥20% from baseline

Time frame
From spinal injection through end of surgery
3

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.

Time frame
From spinal injection through end of surgery

Secondary outcomes

1

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).

Time frame
From spinal injection through end of surgery
2

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).

Time frame
Throughout surgery
3

Incidence of Bradycardia

Proportion of participants experiencing bradycardia, defined as heart rate \<50 beats per minute requiring treatment.

Time frame
From spinal injection through end of surgery
4

Incidence of Nausea and Vomiting

Proportion of participants experiencing nausea and/or vomiting during the intraoperative and immediate postoperative period.

Time frame
From spinal injection through end of surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: