このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Predictors of Unilateral Spinal Block Success (UNISS)

2026年5月6日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

318

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Unilateral Spinal Block Success Rate
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Rate of unilateral spinal anesthesia success by age
時間枠:Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Intraoperative period
Rate of unilateral spinal anesthesia success by BMI
時間枠:Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Intraoperative period
Rate of unilateral spinal anesthesia success by position
時間枠: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
時間枠: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
時間枠:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by needle gauge.
Intraoperative period
Rate of unilateral spinal anesthesia success by local aneshtetic dose
時間枠: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
時間枠: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
時間枠: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
時間枠:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by intervertebral level (L1-2,L2-3,L3-L4 ,L4-L5).
Intraoperative period

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Derya Arslan Yurtlu, MD、İzmir City Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年8月10日

一次修了 (実際)

2026年2月1日

研究の完了 (実際)

2026年2月1日

試験登録日

最初に提出

2026年4月9日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月12日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be shared due to patient confidentiality and institutional data protection policies

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する