Hypotension Drug-InducedNCT07597148
Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
A study testing Lateral Decubitus Positioning and Immediate Supine Positioning in people with Hypotension Drug-Induced and Spinal Aneshtesia, run by University of Health Sciences Balikesir Hospital Eduation and Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension Drug-Induced, Spinal Aneshtesia, Geriatric
- What is being tested?
- Lateral Decubitus Positioning and Immediate Supine Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- Emergency surgery
- Severe hypovolemia or active bleeding
- Advanced dementia or inability to communicate
- Body mass index above 40 kg/m²
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- Lateral Decubitus Positioning, Immediate Supine Positioning
- Keywords
- hypotension, spinal anesthesia, lateral decubitus position, geriatric, hyperbaric bupivacaine, unilateral spinal block, hemodynamic stability, orthopedic surgery, ASA III-IV
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Decubitus PositioningOther
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 PositioningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Immediate Supine Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From spinal anesthesia to 15 minutes after administration
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 15 and 30 minutes after spinal anesthesia administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypotension Drug-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: lateral decubitus position (operative side down) for 15 minutes after spinal anesthesia versus immediate supine position after spinal anesthesia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597148
- Sponsor's protocol ID
- hasanduman2
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
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.
PubMed 16163920Simonin 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.
PubMed 36135347Guay 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.
PubMed 26899415Gill 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.
PubMed 36260323Becher 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.
PubMed 34261884
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07597148
- Acronym / sponsor ID
- hasanduman2
- Keywords
- hypotension, spinal anesthesia, lateral decubitus position, geriatric, hyperbaric bupivacaine, unilateral spinal block, hemodynamic stability, orthopedic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and ResearchOther government
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups: lateral decubitus position (operative side down) for 15 minutes after spinal anesthesia versus immediate supine position after spinal anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Group L: Lateral Decubitus Position | Experimental | Other: Lateral Decubitus PositioningAfter 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. |
| Group S: Immediate Supine Position | Active comparator | Other: Immediate Supine PositioningAfter 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral Decubitus PositioningAfter 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. | Other | Group L: Lateral Decubitus Position |
| Immediate Supine PositioningAfter 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. | Other | Group S: Immediate Supine Position |
Primary outcome
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.
5 secondary outcomes
Incidence of Bradycardia
Time frame: From spinal anesthesia to 30 minutes after administration
Ephedrine Requirement
Time frame: From spinal anesthesia to 30 minutes after administration
Atropine Requirement
Time frame: From spinal anesthesia to 30 minutes after administration
Maximum Sensory Block Level
Time frame: From spinal anesthesia to 30 minutes after administration
Incidence of Unilateral Sensory Block
Time frame: 15 and 30 minutes after spinal anesthesia administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 16163920Kelly 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.
- Background: PubMed 36135347Simonin 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.
- Background: PubMed 26899415Guay 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.
- Background: PubMed 36260323Gill 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.
- Background: PubMed 34261884Becher 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.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Decubitus Positioning and Immediate Supine Positioning in people with Hypotension Drug-Induced and Spinal Aneshtesia, run by University of Health Sciences Balikesir Hospital Eduation and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan Duman, M.D. (+905547317716, hasanduman.1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hypotension (time frame: From spinal anesthesia to 15 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07597148, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.