Ultrasound-guided Versus Landmark-based Spinal Anesthesia in Obese Parturients Undergoing Cesarean Section

NCT07549776 | Completed

• 1 other identifier: 0107-DG-0080-OEAIDE-I
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is the most commonly used technique for cesarean section. However, in obese parturients, identification of the optimal puncture site using anatomical landmark palpation can be challenging due to altered anatomy. Ultrasound has been proposed as a tool to improve localization of the puncture site. This study is a prospective randomized controlled trial including 100 obese parturients undergoing cesarean section under spinal anesthesia. Participants are randomly assigned to one of two groups: an ultrasound group, in which the puncture site is identified using preprocedural ultrasound, and a landmark group, in which the puncture site is determined using anatomical landmark palpation. The primary outcome is the first-attempt success rate. Secondary outcomes include the number of attempts, needle redirections, need for rescue interventions, incidence of adverse events during puncture, and procedural times.

Conditions

Obesity; Cesarean Section

Keywords

Ultrasonography; Spinal anesthesia; Cesarean section; Obesity; Neuraxial anesthesia

Outcome Measures

Primary Outcomes (1)

• First-attempt success rate of spinal anesthesia

  Successful cerebrospinal fluid return after the first needle insertion without redirection.

  During the spinal anesthesia procedure

Secondary Outcomes (7)

• Number of puncture attempts

  During the spinal anesthesia procedure

• Number of needle redirections

  During the spinal anesthesia procedure

• Need for rescue intervention

  During the spinal anesthesia procedure

• Incidence of paresthesia

  During the spinal anesthesia procedure

• Incidence of vascular puncture

  During the spinal anesthesia procedure

Study Arms (2)

Ultrasound-guided group

ACTIVE COMPARATOR

Preprocedural ultrasound was used to identify and mark the optimal puncture site in obese parturients undergoing cesarean section (n = 50).

Procedure: Ultrasound-guided preprocedural marking

Landmark-based group

ACTIVE COMPARATOR

The puncture site was identified using anatomical landmark palpation in obese parturients undergoing cesarean section (n = 50)

Procedure: Landmark-based palpation

Interventions

Ultrasound-guided preprocedural marking PROCEDURE

Preprocedural ultrasound is used to identify and mark the optimal puncture site before spinal anesthesia.

Ultrasound-guided group

Landmark-based palpation PROCEDURE

The puncture site is identified using anatomical landmark palpation before spinal anesthesia.

Landmark-based group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Pregnant women undergoing cesarean section
• Body mass index (BMI) ≥ 30 kg/m² at the time of cesarean section
• Scheduled for cesarean section under spinal anesthesia

You may not qualify if:

• Congenital spinal deformities
• History of spinal surgery
• Coagulopathy
• Infection at the puncture site
• Allergy to local anesthetics
• Emergency cesarean section (NICE category 1)

Sponsors & Collaborators

• Instituto Nacional Materno Perinatal, Peru: lead

Study Sites (1)

National Maternal and Perinatal Institute

Lima, Lima Province, 15001, Peru

Location

Related Publications (4)

• Khoo AK, Huynh A, Pelecanos A, Eley VA. Does preprocedural ultrasound increase first-pass success in obese adults undergoing neuraxial anesthesia? A systematic review. Health Sci Rep. 2024;7:e70039.

  BACKGROUND

• Zhang Y, Peng M, Wei J, et al. Ultrasound-guided versus traditional localization in intraspinal anesthesia: a systematic review and network meta-analysis. BMJ Open. 2023;13:e071253

  BACKGROUND

• Li M, Ni X, Xu Z, et al. Ultrasound-assisted technology versus the conventional landmark method in spinal anesthesia for cesarean delivery in obese parturients: a randomized controlled trial. Anesth Analg. 2019;129(1):155-161.

  BACKGROUND

• Perlas A, Chaparro LE, Chin KJ. Lumbar neuraxial ultrasound for spinal and epidural anesthesia: a systematic review and meta-analysis. Reg Anesth Pain Med. 2016;41(2):251-260.

  BACKGROUND

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

• Eddisson R Quispe Pilco, MD

  National Maternal and Perinatal Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of the operators was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist, Department of Anesthesia

Model Details: Participants are randomly assigned to one of two parallel groups: ultrasound-guided preprocedural marking or landmark-based palpation for spinal anesthesia.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months after publication and ending 12 months after publication
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author via email. Data will be shared after approval of the proposal and signing of a data access agreement.

Locations

PE (1)