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NCT Number: NCT07581561

Predictors of Unilateral Spinal Block Success

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İzmir City Hospital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Unilateral Spinal Block Success Rate

    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.

Secondary outcomes

  1. Rate of unilateral spinal anesthesia success by age

    Time frame: Intraoperative period

    Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.

  2. Rate of unilateral spinal anesthesia success by BMI

    Time frame: Intraoperative period

    Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.

  3. Rate of unilateral spinal anesthesia success by position

    Time frame: Intraoperative period

    Proportion (%) of unilateral spinal anesthesia success by patient positioning during injection (lateral vs sitting).

  4. Rate of unilateral spinal anesthesia success by needle type

    Time frame: Intraoperative period

    Proportion (%) of unilateral spinal anesthesia success by spinal needle type (Quincke vs pencil-point).

  5. Rate of unilateral spinal anesthesia success by needle gauge

    Time frame: Intraoperative period

    Proportion (%) of unilateral spinal anesthesia success by needle gauge.

  6. Rate of unilateral spinal anesthesia success by local aneshtetic dose

    Time frame: Intraoperative period

    Proportion (%) of unilateral spinal anesthesia success by administered local anesthetic dose (mg).

  7. Rate of unilateral spinal anesthesia success by injection speed

    Time frame: Intraoperative period

    Proportion (%) of unilateral spinal anesthesia success by injection speed category (faster vs ≤1 mL/5 s).

  8. Sensory Block Level and Distribution

    Time frame: Intraoperative period

    Assessment of sensory block level (dermatomal level) and comparison between operated and non-operated sides.

  9. Rate of unilateral spinal anesthesia success by intervertebral level of spinal injection

    Time frame: Intraoperative period

    Proportion (%) of unilateral spinal anesthesia success by intervertebral level (L1-2,L2-3,L3-L4 ,L4-L5).

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

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

Acronym: UNISS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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