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Predictors of Unilateral Spinal Block Success

Determination of Factors Affecting Success in Unilateral Spinal Anesthesia: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07581561
Acronym
UNISS
Enrollment
318
Registered
2026-05-12
Start date
2025-08-10
Completion date
2026-02-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Anaesthesia, Spinal Aneshtesia, Unilateral Spinal Anesthesia

Keywords

unilateral spinal anesthesia, spinal block success, regional anesthesia, anesthesia technique, block distribution, lower extremity surgery

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Izmir City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 18-65 years * ASA physical status I-III * Undergoing elective unilateral lower extremity surgery under spinal anesthesia * Provided written informed consent

Exclusion criteria

* ASA IV patients * Known allergy to local anesthetics * Contraindications to spinal anesthesia * Decompensated congestive heart failure * Hemodynamic instability (including sepsis, septic shock, or need for inotropic support) * Pregnancy * Patients with vertebral anomalies (e.g., scoliosis, vertebral fractures) preventing proper positioning

Design outcomes

Primary

MeasureTime frameDescription
Unilateral Spinal Block Success RateIntraoperative period (within first 30 minutes after spinal anesthesiaSuccessful 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.

Secondary

MeasureTime frameDescription
Rate of unilateral spinal anesthesia success by ageIntraoperative periodProportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Rate of unilateral spinal anesthesia success by BMIIntraoperative periodProportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Rate of unilateral spinal anesthesia success by positionIntraoperative periodProportion (%) of unilateral spinal anesthesia success by patient positioning during injection (lateral vs sitting).
Rate of unilateral spinal anesthesia success by needle typeIntraoperative periodProportion (%) of unilateral spinal anesthesia success by spinal needle type (Quincke vs pencil-point).
Rate of unilateral spinal anesthesia success by needle gaugeIntraoperative periodProportion (%) of unilateral spinal anesthesia success by needle gauge.
Rate of unilateral spinal anesthesia success by local aneshtetic doseIntraoperative periodProportion (%) of unilateral spinal anesthesia success by administered local anesthetic dose (mg).
Rate of unilateral spinal anesthesia success by injection speedIntraoperative periodProportion (%) of unilateral spinal anesthesia success by injection speed category (faster vs ≤1 mL/5 s).
Sensory Block Level and DistributionIntraoperative periodAssessment of sensory block level (dermatomal level) and comparison between operated and non-operated sides.
Rate of unilateral spinal anesthesia success by intervertebral level of spinal injectionIntraoperative periodProportion (%) of unilateral spinal anesthesia success by intervertebral level (L1-2,L2-3,L3-L4 ,L4-L5).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORDerya Arslan Yurtlu, MD

Izmir City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026