İzmir City Hospital
Izmir, Turkey (Türkiye)
NCT Number: NCT07581561
This prospective observational study aims to determine the factors affecting the success of unilateral spinal anesthesia in patients undergoing orthopedic lower extremity surgery. Unilateral spinal anesthesia is preferred to minimize unwanted effects such as hypotension and to provide more stable hemodynamic conditions, especially in vulnerable patient populations.
Unilateral spinal anesthesia is defined as achieving sensory and motor block predominantly on the operated side without significant contralateral spread. However, the factors influencing the success of this technique have not been fully clarified.
This study will evaluate various patient-related and procedure-related factors, including age, sex, body mass index, patient positioning, needle type and orientation, injection technique and local anesthetic dose. The primary outcome is the success of unilateral spinal anesthesia, defined as the absence of contralateral block.
The results of this study are expected to contribute to improving clinical practice by identifying major and minor factors affecting block success and optimizing anesthesia techniques.
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Notify Me18 year–65 year
All sexes
Observational
Izmir, Turkey (Türkiye)
This prospective observational study is designed to investigate the factors influencing the success of unilateral spinal anesthesia in patients undergoing lower extremity orthopedic surgery.
Spinal anesthesia is widely used in lower extremity procedures; however, it may be associated with hemodynamic instability such as hypotension. Unilateral spinal anesthesia has been proposed as a technique to limit sympathetic blockade and maintain more stable hemodynamic conditions. Despite its advantages, the determinants of successful unilateral block remain unclear.
Patients aged between 18 and 65 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective lower extremity surgery will be included in the study after providing written informed consent. This study will be conducted in a single tertiary care center.
No intervention will be performed by the investigator. All anesthesia procedures will be carried out according to routine clinical practice. The investigator will record patient demographics, including age, sex, height, weight, and body mass index.
Procedure-related variables such as patient positioning, spinal needle type, needle orientation, injection speed, level of injection, local anesthetic type and dose will be recorded.
Block characteristics will be assessed intraoperatively, including sensory and motor block distribution. The primary outcome is defined as successful unilateral spinal anesthesia, characterized by the absence of contralateral sensory block. Secondary outcomes include factors associated with block success and variability in block characteristics.
Data will be collected using standardized case report forms and analyzed to identify factors influencing the success of unilateral spinal anesthesia. The results of this study are expected to contribute to optimizing anesthesia techniques and improving patient safety.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Intraoperative period (within first 30 minutes after spinal anesthesia
Successful unilateral spinal anesthesia defined as the absence of contralateral sensory block, assessed by pinprick test and bromage scale within the first 20 minutes after spinal anesthesia.
Time frame: Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Time frame: Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Time frame: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by patient positioning during injection (lateral vs sitting).
Time frame: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by spinal needle type (Quincke vs pencil-point).
Time frame: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by needle gauge.
Time frame: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by administered local anesthetic dose (mg).
Time frame: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by injection speed category (faster vs ≤1 mL/5 s).
Time frame: Intraoperative period
Assessment of sensory block level (dermatomal level) and comparison between operated and non-operated sides.
Time frame: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by intervertebral level (L1-2,L2-3,L3-L4 ,L4-L5).
Izmir City Hospital
Other Gov
Determination of Factors Affecting Success in Unilateral Spinal Anesthesia: A Prospective Observational Study
Acronym: UNISS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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