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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From spinal anesthesia to 30 minutes after administration |
| Ephedrine Requirement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasan Duman, M.D. | Contact | +905547317716 | hasanduman.1991@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16163920 | Background | 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. | |
| 36135347 | 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. |
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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).
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Two parallel groups: lateral decubitus position (operative side down) for 15 minutes after spinal anesthesia versus immediate supine position after spinal anesthesia.
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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.
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| 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. |
|
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 | 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 | 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 | 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 |
| 26899415 | 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. |
| 36260323 | 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. |
| 34261884 | 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. |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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