Upper Extremity Position and Intraocular Pressure During Spinal Anesthesia: A Randomized Controlled Trial
UEP-IOP
1 other identifier
interventional
60
1 country
1
Brief Summary
This prospective randomized controlled trial evaluated the effect of two upper extremity positions on intraocular pressure (IOP) in adult patients undergoing surgery under spinal anesthesia. Participants were randomly assigned to either an arms-at-sides position or a hands-on-chest position. IOP was measured in the right eye using an Icare ic200 rebound tonometer at predefined perioperative time points. Hemodynamic parameters, including mean arterial pressure, heart rate, and oxygen saturation, were also recorded. The primary outcome was the change in IOP from baseline to 30 minutes after application of the assigned upper extremity position between the two upper extremity position groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2026
CompletedFirst Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedSeptember 30, 2026
September 1, 2026
3 months
February 12, 2026
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Intraocular Pressure From Baseline to 30 Minutes
Intraocular pressure was measured in the right eye using an Icare ic200 rebound tonometer. The primary outcome was the change in intraocular pressure from baseline before spinal anesthesia to 30 minutes after application of the assigned upper extremity position between the two study groups.
Baseline before spinal anesthesia and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
Secondary Outcomes (2)
Change in Intraocular Pressure From Baseline to 15 Minutes
Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position
Mean Arterial Pressure
Baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before positioning, and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
Study Arms (2)
Arms-at-Sides Position
EXPERIMENTALParticipants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both arms were positioned alongside the body, parallel to the torso, with the palms facing upward, and this position was maintained for approximately 30 minutes until the final T45 measurement.
Hands-on-Chest Position
EXPERIMENTALParticipants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both upper extremities were adducted with the elbows flexed, and the open hands were placed one over the other on the anterior chest wall. This position was maintained for approximately 30 minutes until the final T45 measurement.
Interventions
Participants were assigned to one of two upper extremity positions after the T15 intraocular pressure measurement: arms positioned alongside the body or hands positioned over the chest. The assigned position was maintained for approximately 30 minutes until the final T45 intraocular pressure measurement.
Eligibility Criteria
You may qualify if:
- Age between 18 and 80 years
- ASA physical status I-III
- Scheduled for elective open inguinal hernia repair under spinal anesthesia
- Ability to undergo intraocular pressure measurement
- Provision of written informed consent
You may not qualify if:
- History of glaucoma or ocular hypertension
- Previous ocular surgery or ocular trauma
- Active ocular disease or infection
- Contraindication to spinal anesthesia
- Inability to cooperate with intraocular pressure measurements
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Elazığ Fethi Sekin City Hospital
Elâzığ, Outside of the US, 23200, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Due to the visible nature of the upper extremity positioning intervention, blinding of participants, care providers, and the outcome assessor was not feasible. The investigator performing intraocular pressure measurements was not involved in randomization sequence generation or group assignment, and measurements were standardized using the same device, prespecified eye, neutral head and neck position, and predefined measurement quality criteria.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 20, 2026
Study Start
November 20, 2025
Primary Completion
February 10, 2026
Study Completion
February 10, 2026
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share