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

NCT07597148 | Not Yet Recruiting

• 1 other identifier: hasanduman2
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypotension Drug-Induced; Spinal Aneshtesia; Geriatric; Orthopedic Surgery Patients

Keywords

hypotension; spinal anesthesia; lateral decubitus position; geriatric; hyperbaric bupivacaine; unilateral spinal block; hemodynamic stability; orthopedic surgery; ASA III-IV

Outcome Measures

Primary Outcomes (1)

• 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.

  From spinal anesthesia to 15 minutes after administration

Secondary Outcomes (5)

• Incidence of Bradycardia

  From spinal anesthesia to 30 minutes after administration

• Ephedrine Requirement

  From spinal anesthesia to 30 minutes after administration

• Atropine Requirement

  From spinal anesthesia to 30 minutes after administration

• Maximum Sensory Block Level

  From spinal anesthesia to 30 minutes after administration

• Incidence of Unilateral Sensory Block

  15 and 30 minutes after spinal anesthesia administration

Study Arms (2)

Group L: Lateral Decubitus Position

EXPERIMENTAL

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

Group S: Immediate Supine Position

ACTIVE COMPARATOR

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

Interventions

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.

Group L: Lateral Decubitus Position

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.

Group S: Immediate Supine Position

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Health Sciences Balikesir Hospital Eduation and Research: lead

Related Publications (5)

• Kelly JD, McCoy D, Rosenbaum SH, Brull SJ. Haemodynamic changes induced by hyperbaric bupivacaine during lateral decubitus or supine spinal anaesthesia. Eur J Anaesthesiol. 2005 Sep;22(9):717-22. doi: 10.1017/s0265021505001183.

  PMID: 16163920 BACKGROUND

• Simonin M, Delsuc C, Meuret P, Caruso L, Deleat-Besson R, Lamblin A, Huriaux L, Abraham P, Bidon C, Giai J, Riche B, Rimmele T. Hypobaric Unilateral Spinal Anesthesia Versus General Anesthesia for Hip Fracture Surgery in the Elderly: A Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1262-1270. doi: 10.1213/ANE.0000000000006208. Epub 2022 Sep 22.

  PMID: 36135347 BACKGROUND

• Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2(2):CD000521. doi: 10.1002/14651858.CD000521.pub3.

  PMID: 26899415 BACKGROUND

• Gill TM, Vander Wyk B, Leo-Summers L, Murphy TE, Becher RD. Population-Based Estimates of 1-Year Mortality After Major Surgery Among Community-Living Older US Adults. JAMA Surg. 2022 Dec 1;157(12):e225155. doi: 10.1001/jamasurg.2022.5155. Epub 2022 Dec 14.

  PMID: 36260323 BACKGROUND

• Becher RD, Vander Wyk B, Leo-Summers L, Desai MM, Gill TM. The Incidence and Cumulative Risk of Major Surgery in Older Persons in the United States. Ann Surg. 2023 Jan 1;277(1):87-92. doi: 10.1097/SLA.0000000000005077. Epub 2021 Jul 14.

  PMID: 34261884 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hasan Duman, M.D.

CONTACT

+905547317716; hasanduman.1991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator assessing sensory block levels and recording hemodynamic parameters was blinded to group allocation. Blinding of participants and care providers was not possible due to the nature of the positional intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Two parallel groups: lateral decubitus position (operative side down) for 15 minutes after spinal anesthesia versus immediate supine position after spinal anesthesia.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share