Clinical Trials Directory

Trials / Completed

CompletedNCT07327801

The Impact of Ultrasound-Guided Spinal Anesthesia

Impact of Ultrasound Guidance on the Performance of Spinal Anesthesia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
136 (actual)
Sponsor
Military Hospital of Tunis · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEConventional spinal anesthesiaThe spinous processes were then palpated to precisely locate the targeted intervertebral space
DEVICEUltrasound-guided spinal anesthesiaA 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

Timeline

Start date
2025-02-01
Primary completion
2025-05-31
Completion
2025-07-30
First posted
2026-01-08
Last updated
2026-01-08

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT07327801. Inclusion in this directory is not an endorsement.