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Predictors of Unilateral Spinal Block Success (UNISS)

2026년 5월 6일 업데이트: Derya Arslan Yurtlu, Izmir City Hospital

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

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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (실제)

318

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

터키 (Türkiye)
- - Izmir, 터키 (Türkiye)
    - İzmir City Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Adult patients aged 18-65 years with ASA physical status I-III undergoing elective unilateral lower extremity surgery under spinal anesthesia in a single tertiary care center.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
patients undergoing unilateral spinal anesthesia Patients aged 18-65 years with ASA physical status I-III undergoing elective unilateral lower extremity surgery under spinal anesthesia.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Unilateral Spinal Block Success Rate 기간: 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.	Intraoperative period (within first 30 minutes after spinal anesthesia

2차 결과 측정

결과 측정	측정값 설명	기간
Rate of unilateral spinal anesthesia success by age 기간: Intraoperative period	Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.	Intraoperative period
Rate of unilateral spinal anesthesia success by BMI 기간: Intraoperative period	Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.	Intraoperative period
Rate of unilateral spinal anesthesia success by position 기간: Intraoperative period	Proportion (%) of unilateral spinal anesthesia success by patient positioning during injection (lateral vs sitting).	Intraoperative period
Rate of unilateral spinal anesthesia success by needle type 기간: Intraoperative period	Proportion (%) of unilateral spinal anesthesia success by spinal needle type (Quincke vs pencil-point).	Intraoperative period
Rate of unilateral spinal anesthesia success by needle gauge 기간: Intraoperative period	Proportion (%) of unilateral spinal anesthesia success by needle gauge.	Intraoperative period
Rate of unilateral spinal anesthesia success by local aneshtetic dose 기간: Intraoperative period	Proportion (%) of unilateral spinal anesthesia success by administered local anesthetic dose (mg).	Intraoperative period
Rate of unilateral spinal anesthesia success by injection speed 기간: Intraoperative period	Proportion (%) of unilateral spinal anesthesia success by injection speed category (faster vs ≤1 mL/5 s).	Intraoperative period
Sensory Block Level and Distribution 기간: Intraoperative period	Assessment of sensory block level (dermatomal level) and comparison between operated and non-operated sides.	Intraoperative period
Rate of unilateral spinal anesthesia success by intervertebral level of spinal injection 기간: Intraoperative period	Proportion (%) of unilateral spinal anesthesia success by intervertebral level (L1-2,L2-3,L3-L4 ,L4-L5).	Intraoperative period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Izmir City Hospital

수사관

수석 연구원: Derya Arslan Yurtlu, MD, İzmir City Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 10일

기본 완료 (실제)

2026년 2월 1일

연구 완료 (실제)

2026년 2월 1일

연구 등록 날짜

최초 제출

2026년 4월 9일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)