An interventional study of Lateral Decubitus Positioning and Immediate Supine Positioning in Hypotension Drug-Induced, Spinal Aneshtesia and Geriatric, sponsored by University of Health Sciences Balikesir Hospital Eduation and Research. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University of Health Sciences Balikesir Hospital Eduation and Research · Not applicable, Interventional, and Prevention
Spinal anesthesia is a common and preferred anesthetic technique for lower extremity orthopedic surgery in elderly patients. However, it can cause a significant drop in blood pressure (hypotension), especially in high-risk older patients with multiple medical conditions. This complication can lead to serious consequences such as heart attack, stroke, or death in vulnerable patients.
This study investigates whether keeping patients in a lateral (side-lying) position for 15 minutes after spinal anesthesia - instead of immediately turning them onto their back (supine position) - can reduce the risk of hypotension. When a patient lies on their side after receiving spinal anesthesia with a heavy (hyperbaric) local anesthetic, the medication tends to stay concentrated on the lower (operative) side, resulting in a more limited nerve block. This may help preserve blood pressure stability.
We will enroll 70 patients aged 65 years or older with high anesthetic risk (ASA physical status III or IV) scheduled for unilateral lower extremity orthopedic surgery under spinal anesthesia. Patients will be randomly assigned to two groups: one group will be kept in the lateral decubitus position (operative side down) for 15 minutes before being turned supine, and the other group will be turned supine immediately after spinal anesthesia. Blood pressure, heart rate, and oxygen saturation will be monitored continuously. The primary outcome is the incidence of hypotension during the first 15 minutes after spinal anesthesia.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 70 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →University of Health Sciences Balikesir Hospital Eduation and Research is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
After spinal anesthesia with 12 mg 0.5% hyperbaric bupivacaine in the sitting position, patients are immediately placed in the lateral decubitus position with the operative side down and maintained for 15 minutes, then turned supine.
Other: Lateral Decubitus Positioning
After spinal anesthesia with 12 mg 0.5% hyperbaric bupivacaine in the sitting position, patients are immediately turned to the supine position and maintained throughout the procedure.
Other: Immediate Supine Positioning
After spinal anesthesia with 12 mg of 0.5% hyperbaric bupivacaine administered in the sitting position, patients are immediately placed in the lateral decubitus position with the operative side down. This position is maintained for 15 minutes to allow gravity-dependent concentration of the hyperbaric local anesthetic on the operative side, achieving predominantly unilateral sympathetic block. Patients are then repositioned supine for surgery.
After spinal anesthesia with 12 mg of 0.5% hyperbaric bupivacaine administered in the sitting position, patients are immediately placed in the supine position. This results in bilateral distribution of the hyperbaric local anesthetic and serves as the active comparator.
Incidence of Hypotension
Hypotension defined as a decrease of 20% or more from baseline mean arterial pressure (MAP) or MAP below 65 mmHg, occurring at any time point between 1 and 15 minutes after spinal anesthesia.
Time frame: From spinal anesthesia to 15 minutes after administration
Incidence of Bradycardia
Bradycardia defined as heart rate below 50 beats per minute at any time point during the study period, treated with intravenous atropine 0.5 mg bolus.
Time frame: From spinal anesthesia to 30 minutes after administration
Ephedrine Requirement
Total dose of ephedrine (mg) administered intravenously for treatment of hypotension. Ephedrine given as 5-10 mg IV bolus, repeated if necessary.
Time frame: From spinal anesthesia to 30 minutes after administration
Atropine Requirement
Total dose of atropine (mg) administered intravenously for treatment of bradycardia. Atropine given as 0.5 mg IV bolus when heart rate falls below 50 beats per minute.
Time frame: From spinal anesthesia to 30 minutes after administration
Maximum Sensory Block Level
Highest dermatomal level of sensory block assessed by pin-prick test on the operative side, recorded as thoracic dermatome level (T6-T12).
Time frame: From spinal anesthesia to 30 minutes after administration
Incidence of Unilateral Sensory Block
Proportion of patients achieving unilateral block, defined as complete sensory block at T10 or above on the operative side with no block below T12 on the contralateral side, assessed at 15 and 30 minutes after spinal anesthesia.
Time frame: 15 and 30 minutes after spinal anesthesia administration
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared due to the absence of institutional infrastructure for data sharing and patient privacy considerations under Turkish personal data protection legislation (KVKK - Kişisel Verilerin Korunması Kanunu).
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Balikesir Hospital Eduation and Research