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NCT Number: NCT07597148

Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients

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.

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Key information

Conditions

Hypotension Drug-Induced Cardiovascular Diseases Geriatric Hypotension Orthopedic Surgery Patients Spinal Aneshtesia Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 years or older
  • ASA physical status classification III or IV
  • Scheduled for unilateral lower extremity orthopedic surgery (hip fracture, femur fracture, knee arthroplasty, tibia-fibula fracture, or similar procedures)
  • Eligible for spinal anesthesia
  • Written informed consent obtained

Exclusion criteria

  • Contraindications to spinal anesthesia (coagulopathy, recent anticoagulant or antiplatelet use without adequate washout period, local infection at injection site)
  • Severe neurological disease or pre-existing motor or sensory deficit
  • Significant spinal deformity (severe scoliosis, kyphosis) or history of previous spinal surgery
  • Known allergy to local anesthetics
  • Decompensated heart failure (ejection fraction below 30%)
  • Uncontrolled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
  • Emergency surgery
  • Severe hypovolemia or active bleeding
  • Advanced dementia or inability to communicate
  • Body mass index above 40 kg/m²
  • Refusal to participate

Treatment and study plan

Lateral Decubitus Positioning

Other

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.

Immediate Supine Positioning

Other

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.

Primary outcomes

  1. Incidence of Hypotension

    Time frame: From spinal anesthesia to 15 minutes after administration

    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.

Secondary outcomes

  1. Incidence of Bradycardia

    Time frame: From spinal anesthesia to 30 minutes after administration

    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.

  2. Ephedrine Requirement

    Time frame: From spinal anesthesia to 30 minutes after administration

    Total dose of ephedrine (mg) administered intravenously for treatment of hypotension. Ephedrine given as 5-10 mg IV bolus, repeated if necessary.

  3. Atropine Requirement

    Time frame: From spinal anesthesia to 30 minutes after administration

    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.

  4. Maximum Sensory Block Level

    Time frame: From spinal anesthesia to 30 minutes after administration

    Highest dermatomal level of sensory block assessed by pin-prick test on the operative side, recorded as thoracic dermatome level (T6-T12).

  5. Incidence of Unilateral Sensory Block

    Time frame: 15 and 30 minutes after spinal anesthesia administration

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hasan Duman, M.D.

CONTACT

[email protected]

+905547317716

Sponsors and collaborators

Lead sponsor

University of Health Sciences Balikesir Hospital Eduation and Research

Other Gov

Registry information

Official study title

The Effects of Lateral Decubitus Positioning After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients Undergoing Lower Extremity Orthopedic Surgery: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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