The Impact of Ultrasound-Guided Spinal Anesthesia

NCT07327801 | Completed

• 1 other identifier: 54/2024/clpp/militaryhosptunis
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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

Ultrasound Guidance; Spinal Anesthesia; Procedural Performance; Conventional Palpation Technique

Outcome Measures

Primary Outcomes (1)

• procedure time

  60sec

Study Arms (2)

Conventional spinal anesthesia

ACTIVE COMPARATOR

The operator began by palpating the posterior superior iliac spines to mentally determine the Tuffier's line, which roughly corresponds to the L4-L5 intervertebral space. The spinous processes were then palpated to precisely locate the targeted intervertebral space. The needle was subsequently inserted until cerebrospinal fluid return was obtained, and the anesthetic agent was administered slowly

Device: Conventional spinal anesthesia

Ultrasound-guided spinal anesthesia

ACTIVE COMPARATOR

The operator set up the sterile equipment, which included an ultrasound machine equipped with a low-frequency convex probe (2-5 MHz). The probe, previously disinfected, was covered with a sterile sheath containing sterile coupling gel. First, the transducer was positioned in a paramedian sagittal plane, placed 1-2 cm lateral to the spinous processes. The sacrum was identified as a flat, hyperechoic structure producing a marked acoustic shadow, serving as the starting landmark for identifying successive lumbar intervertebral spaces. By gradually sliding the transducer cephalad, the vertebral laminae appeared as hyperechoic lines alternating with their posterior acoustic shadows. The interlaminar spaces, located between two adjacent laminae, form true acoustic windows that allow visualization of the underlying neuraxial structures. The exploration continued until the intervertebral space deemed optimal for puncture was identified. The probe was then switched to a midline posit

Device: Ultrasound-guided spinal anesthesia

Interventions

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

Ultrasound-guided spinal anesthesia

Conventional spinal anesthesia DEVICE

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

Conventional spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Military Hospital of Tunis: lead

Study Sites (1)

Military Hospital of Tunis

Tunis, Tunisia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: July 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

TU (1)