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Predictors of Epidural Depth in Percutaneous Nephrolithotomy and Model Development

2026년 7월 13일 업데이트: Hongbo Zheng, Tongji Hospital

Analysis of Factors Influencing Epidural Depth in Patients Undergoing Percutaneous Nephrolithotomy and Development of a Predictive Model

Accurate estimation of epidural depth is critical for safe epidural anesthesia during percutaneous nephrolithotomy (PCNL). Although various imaging modalities can predict epidural depth, they increase healthcare burden and are not always feasible in emergency or bedside settings. Identifying simple, easily obtainable clinical parameters-such as sex, age, and body mass index (BMI)-for predicting epidural depth has become a research priority. However, systematic investigations specifically targeting the Chinese population remain scarce. This retrospective study aims to identify independent factors influencing epidural depth in PCNL patients and to develop simple, level-specific predictive models for different puncture sites, thereby providing a practical reference for clinical epidural anesthesia.

연구 개요

상태

아직 모집하지 않음

상세 설명

Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical procedure for removal of kidney stones larger than 2 cm and is established as the gold standard for the management of complex renal calculi. This procedure may be performed under either general anesthesia or regional anesthesia, including epidural or spinal anesthesia. Accumulating meta-analyses have demonstrated that, compared with general anesthesia, regional anesthesia is associated with reduced postoperative pain scores and lower total hospital costs, without compromising the stone-free rate. Furthermore, in awake patients undergoing regional anesthesia, respiratory movements may generate a so-called "respiratory-synchronous stone fragmentation effect," which facilitates the expulsion of stone debris.

Successful epidural anesthesia relies critically on accurate identification of the epidural space and precise control of puncture depth. Insufficient puncture depth may result in improper catheter placement and subsequent block failure, whereas excessive puncture depth increases the risk of dural puncture, leading to cerebrospinal fluid leakage and post-dural puncture headache. In severe cases, inadvertent injection of a large dose of local anesthetics into the subarachnoid space can cause life-threatening cardiovascular and respiratory depression. Therefore, preprocedural estimation of the skin-to-epidural space distance is of considerable clinical importance.

Although racial differences in epidural depth have been reported, systematic investigations specifically targeting the Chinese population remain scarce. Various imaging modalities, including computed tomography, magnetic resonance imaging, and ultrasound, can be used to predict epidural depth. However, these examinations increase healthcare burden and are not always feasible in emergency or bedside settings. Consequently, identifying simple, easily obtainable clinical parameters-such as sex, age, and body mass index (BMI)-for predicting epidural depth has become a research priority.

In this context, the present study aimed to identify factors influencing epidural depth through a retrospective analysis of clinical data from PCNL patients and to develop simple, level-specific predictive models for different puncture sites, thereby providing a practical reference for clinical epidural anesthesia.

연구 유형

관찰

등록 (추정된)

3278

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

    • Hubei
      • Wuhan, Hubei, 중국, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 연락하다:
        • 연락하다:

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 who underwent PCNL under continuous epidural anesthesia between January 2014 and December 2025. All patients were treated at a single academic medical center. Data were extracted from electronic medical records and anesthesia records.

설명

Inclusion Criteria:

  • Age ≥ 18 years
  • Successful epidural puncture and catheter placement using the midline approach
  • Clear documentation of puncture level and puncture depth in the anesthesia record

Exclusion Criteria:

  • Dural puncture during anesthesia (including those who subsequently had a successful repuncture)
  • Use of the paramedian approach for epidural puncture
  • Uncertain epidural anesthesia effect requiring combined general anesthesia
  • Incomplete clinical data

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
T11-T12
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the T11-T12 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
T12-L1
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the T12-L1 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
L1-L2
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the L1-L2 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
L2-L3
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the L2-L3 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Epidural depth
기간: Perioperative/Periprocedural
Epidural depth, defined as the vertical distance from the skin surface to the epidural space measured at the time of puncture using the loss-of-resistance technique via the midline approach. Depth was recorded from the needle shaft markings to the nearest 0.1 cm.
Perioperative/Periprocedural

2차 결과 측정

결과 측정
측정값 설명
기간
Adjusted R²
기간: through study completion, an average of 1 month
The coefficient of determination adjusted for the number of predictors in the model, reflecting the proportion of variance in epidural depth explained by the predictive model at each puncture level. Higher values indicate better model fit.
through study completion, an average of 1 month
Root mean square error (RMSE)
기간: through study completion, an average of 1 month
The square root of the average squared difference between the model-predicted epidural depth and the actual measured depth, expressed in cm. Lower values indicate better predictive accuracy of the model at each puncture level.
through study completion, an average of 1 month

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Hongbo Zheng, MM, Tongji 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 (추정된)

2026년 6월 30일

기본 완료 (추정된)

2026년 8월 31일

연구 완료 (추정된)

2026년 8월 31일

연구 등록 날짜

최초 제출

2026년 7월 5일

QC 기준을 충족하는 최초 제출

2026년 7월 5일

처음 게시됨 (실제)

2026년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices).

IPD 공유 기간

Immediately followingpublication. No end date.

IPD 공유 액세스 기준

Anyone who wishes to access the data.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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