NCT06656793

Brief Summary

Intraspinal anesthesia, traceable to the late 19th century, involves injecting local anesthetics into the spinal canal to block nerve signals, relieving pain and relaxing muscles for surgery. Compared with general anesthesia, it has advantages: smaller impact on the central nervous system, lower drug dosage (reducing systemic poisoning risk), precise block plane control (protecting respiratory/cardiac function), and benefits for mothers and fetuses. However, traditional blind puncture faces challenges in special patients (obese, post-spinal surgery, or pathological cases). It relies on "loss of sensory resistance," prone to misjudgment, leading to dura rupture or spinal cord injury. Obese pregnant women have hard-to-palpate spinous processes; the elderly have ligament calcification/narrowed intervertebral spaces, affecting positioning and ultrasound imaging. Ultrasound guidance has advanced since 1984 (first used to measure epidural space depth, reducing complications). It aids obese pregnant women in locating spinal structures, guides pediatric epidural catheter placement, and improves first-attempt success with better resolution. Adjusting the ultrasound probe to a sagittal midline inner oblique angle solves imaging issues in elderly patients. Clinically, 24G/25G fine needles for ultrasound-guided lumbar puncture may deform; the "needle-in-a-needle" technique (using a larger guide needle) reduces tissue damage and accidental dura puncture, while minimizing skin punctures. Small-sample studies confirm ultrasound's value in vertebral localization and real-time guidance, but the efficacy of ultrasound vs. surface marking remains controversial due to lack of large-sample data. This article provides evidence-based reference via retrospective analysis of 3,597 cases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,597

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 25, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

October 23, 2024

Last Update Submit

September 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Door to skin time (Dts)

    The time from when the patient enters the operating room until the skin incision is made.

    From 1 January 2019 to 29 May 2024

Secondary Outcomes (15)

  • Operative duration

    From the incision to the completion of the surgery

  • Anaesthetic duration

    From the beginning of ultrasound guided spinal anesthesia (UG-SA) to the end of anesthesia

  • PACU duration

    The time from entering PACU to exiting PACU

  • Blood loss

    During operation

  • Other complications

    During operation

  • +10 more secondary outcomes

Study Arms (2)

RT-SA

Real-Time Ultrasound-Guided Spinal Anesthesia

LM-SA

Landmark-Guided Spinal Anesthesia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who received the real-time needle in needle technique UG-SA between 1 January 2019 and 29 May 2024.

You may qualify if:

  • None

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

January 25, 2025

Primary Completion

January 25, 2025

Study Completion

January 25, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations