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OpenTrials
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NCT Number: NCT07327801

The Impact of Ultrasound-Guided Spinal Anesthesia

Neuraxial anesthesia is a commonly employed technique for subumbilical surgical procedures due to its effectiveness and safety profile. The advent of ultrasound technology has introduced the possibility of visualizing anatomical landmarks in real time, thereby facilitating more accurate and potentially safer subarachnoid punctures. This study aims to compare conventional spinal anesthesia, based on palpation, with ultrasound-guided spinal anesthesia, focusing on procedural ease and overall facilitation.

it's a prospective, single-center, randomized, single-blind study. We included patients aged 18 years or older, classified as ASA I or II, scheduled for elective surgery, and who provided written informed consent. Exclusion criteria included failed subarachnoid puncture, conversion to general anesthesia, or the occurrence of major intraoperative complications such as vasovagal episodes or cardiac rhythm disturbances. Participants were randomly assigned, based on a randomization table, into two groups: Group1 (traditional technique), in which spinal anesthesia was performed using the conventional palpation-based method for space localization; and Group2 (ultrasound-guided technique), in which spinal anesthesia was performed under real-time ultrasound guidance. The primary outcome was the total procedure time, measured in seconds from the end of skin antisepsis to the initiation of subarachnoid injection. Secondary outcomes included the number of puncture attempts, the number of needle redirections within the same interspace, the occurrence of procedural incidents, and postoperative complaints such as radicular pain, osseous contact pain, intraoperative paresthesias, and traumatic punctures.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Hospital of Tunis

Tunis, Tunisia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged 18 years or older.
  • Classified as American Society of Anesthesiologists (ASA) physical status I or II.
  • Scheduled for elective surgery under spinal anesthesia.
  • Provided written informed consent.

Exclusion criteria

  • Failed subarachnoid puncture.
  • Conversion to general anesthesia.
  • Occurrence of major intraoperative complications (e.g., vasovagal episodes, cardiac rhythm disturbances).

Treatment and study plan

Conventional spinal anesthesia

Device

The spinous processes were then palpated to precisely locate the targeted intervertebral space

Ultrasound-guided spinal anesthesia

Device

A combined sequence was used, beginning with a longitudinal paramedian scan, followed by a 90-degree rotation to obtain a transverse interspinous view. This allowed for the identification of the spinal canal, after which the puncture was performed using dynamic, out-of-plane guidance

Primary outcomes

  1. procedure time

    Time frame: 60sec

Sponsors and collaborators

Lead sponsor

Military Hospital of Tunis

Other

Registry information

Official study title

Impact of Ultrasound Guidance on the Performance of Spinal Anesthesia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2026
Registry last updated
Jan 8, 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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