Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
12 mai 2026 mis à jour par: University of Health Sciences Balikesir Hospital Eduation and Research
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
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Hasan Duman, M.D.
- Numéro de téléphone: +905547317716
- E-mail: hasanduman.1991@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group L: Lateral Decubitus Position
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.
|
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.
|
|
Comparateur actif: Group S: Immediate Supine Position
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Hypotension
Délai: 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.
|
From spinal anesthesia to 15 minutes after administration
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Bradycardia
Délai: 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.
|
From spinal anesthesia to 30 minutes after administration
|
|
Ephedrine Requirement
Délai: 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.
|
From spinal anesthesia to 30 minutes after administration
|
|
Atropine Requirement
Délai: 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.
|
From spinal anesthesia to 30 minutes after administration
|
|
Maximum Sensory Block Level
Délai: 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).
|
From spinal anesthesia to 30 minutes after administration
|
|
Incidence of Unilateral Sensory Block
Délai: 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.
|
15 and 30 minutes after spinal anesthesia administration
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 août 2026
Achèvement de l'étude (Estimé)
10 août 2026
Dates d'inscription aux études
Première soumission
12 mai 2026
Première soumission répondant aux critères de contrôle qualité
12 mai 2026
Première publication (Réel)
19 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- hasanduman2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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