Conventional Palpation Versus Ultrasound Assisted Spinal Anesthesia in Obstetrics

NCT05846100 | Unknown

• 1 other identifier: Ultrasound spinal anesthesia
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia in obese parturients is commonly difficult yet there are no guidelines to direct best practice. The failure leads to suboptimal patient outcomes. Ultrasonography is now considered standard care for central venous access and regional anesthesia and it can be used to visualize the anatomy of the spine for this procedure. Goal of the study Evaluate the benefits of preprocedural ultrasound scanning to facilitate neuraxial anesthesia and improve the first-attempt success rate in obese parturients.

Conditions

Obese; Cesarean Section; Anesthesia Spinal

Keywords

spinal anesthesia; ultrasound; c section

Outcome Measures

Primary Outcomes (1)

• First pass success rate

  First pass success rate without needle redirection or reinsertion

  before spinal anesthesia

Secondary Outcomes (6)

• Number of puncture attempts

  before spinal anesthesia

• Number of intervertebral interspaces attempted

  before spinal anesthesia

• Requirement of needle redirection

  before spinal anesthesia

• Procedure Time

  before spinal anesthesia

• Patient satisfaction score

  before spinal anesthesia

Study Arms (2)

standard group

PLACEBO COMPARATOR

Fictional ultrasound identification Screen device shut down Intervertebral space identified using the standard palpation

Procedure: fictional preprocedure spinal ultrasound

ultrasound group

ACTIVE COMPARATOR

pre-puncture ultrasound-guided neuraxial anesthesia group

Procedure: Preprocedural spinal ultrasound

Interventions

Preprocedural spinal ultrasound PROCEDURE

a preprocedural spinal ultrasound was performed in a non sterile manner with a sitting position.Both paramedian and transverse planes The intersection of the longitudinal and transverse lines is the point of needle insertion The distance from the skin to the dura mater is noted

ultrasound group

fictional preprocedure spinal ultrasound PROCEDURE

fictional preprocedure spinal ultrasound Fictional ultrasound identification Screen device shut down

standard group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: OBESE PARTURIENTS
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old
• Normal singleton pregnancy
• Gestational age ≥ 37 weeks
• BMI ≥ 30 Kg/ m2 (weight measured on the day before delivery)
• Planned cesarean section
• ASA 2-3

You may not qualify if:

• Spinal anesthesia failure
• Poorly Tolerated spinal anesthesia

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim hospital

Tunis, 2085, Tunisia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amani BEN HAJ YOUSSEF

  Mongi Slim local research ethical committee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amani BEN HAJ YOUSSEF

CONTACT

96874336; amanibhy@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Fictional ultrasound identification Screen device shut down Intervertebral space identified using the standard palpation
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Conventional palpation versus ultrasound assisted spinal anesthesia in obstetrics: A randomized controlled trial

Model Details: All eligible participants scheduled for cesarean delivery were prospectively randomized to 2 groups using computer-generated random numbers: A standard manual palpation group (standard group, n=45) and a pre-puncture ultrasound-guided neuraxial anesthesia group (ultrasound group, n=45).

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)