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NCT Number: NCT07549776

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

Spinal anesthesia is the most commonly used anesthetic technique for cesarean section. However, in obese parturients, identification of the optimal puncture site using anatomical landmark palpation can be challenging because of altered anatomy. Preprocedural ultrasound has been proposed as a tool to improve localization of the puncture site and facilitate neuraxial access.

This is a prospective comparative study included 100 obese parturients undergoing cesarean section under spinal anesthesia. Participants were allocated to one of two comparison groups according to the puncture site localization technique: a preprocedural ultrasound group and an anatomical landmark palpation group.

The primary outcome is the first-attempt success rate, defined as successful cerebrospinal fluid return after the first needle insertion without needle redirection or a new skin puncture. Secondary outcomes include the number of puncture attempts, needle redirections, need for rescue interventions, incidence of paresthesia and vascular puncture during the procedure, and procedural times.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Maternal and Perinatal Institute

Lima, Lima Province, 15001, Peru

About this study

This prospective comparative study aims to evaluate the effectiveness of preprocedural ultrasound-guided marking compared with the conventional anatomical landmark palpation technique for spinal anesthesia in obese parturients undergoing cesarean section.

A total of 100 parturients with a body mass index (BMI) ≥ 30 kg/m² were prospectively allocated to one of two comparison groups according to the puncture site localization technique. In the ultrasound group, the puncture site was identified using preprocedural ultrasound to determine the optimal intervertebral space and needle insertion trajectory. In the landmark group, the puncture site was identified using conventional anatomical landmark palpation.

The primary outcome was the first-attempt success rate, defined as successful cerebrospinal fluid return after the first needle insertion without needle redirection or an additional skin puncture. Secondary outcomes included the number of puncture attempts, needle redirections, need for rescue interventions, incidence of paresthesia and vascular puncture during needle insertion, and procedural times (site identification time, puncture time, and total procedure time).

This study evaluated whether preprocedural ultrasound-guided marking improves the technical performance of spinal anesthesia compared with conventional anatomical landmark palpation in obese parturients undergoing cesarean section.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Ultrasound-guided preprocedural marking

Procedure

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

Landmark-based palpation

Procedure

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

Primary outcomes

  1. First-attempt success rate of spinal anesthesia

    Time frame: During the spinal anesthesia procedure

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

Secondary outcomes

  1. Number of puncture attempts

    Time frame: During the spinal anesthesia procedure

    Total number of needle insertions required to achieve successful spinal anesthesia

  2. Number of needle redirections

    Time frame: During the spinal anesthesia procedure

    Number of needle redirections during a single puncture attempt

  3. Need for rescue intervention

    Time frame: During the spinal anesthesia procedure

    Requirement of assistance by a more experienced operator to complete the procedure

  4. Incidence of paresthesia

    Time frame: During the spinal anesthesia procedure

    Occurrence of paresthesia during needle insertion

  5. Incidence of vascular puncture

    Time frame: During the spinal anesthesia procedure

    Occurrence of vascular puncture during needle insertion

  6. Total procedure time

    Time frame: During the spinal anesthesia procedure

    Time from initial identification of the puncture site to successful cerebrospinal fluid return

  7. Puncture time

    Time frame: During the spinal anesthesia procedure

    Time from needle insertion to successful cerebrospinal fluid return

Sponsors and collaborators

Lead sponsor

Instituto Nacional Materno Perinatal, Peru

Other

Registry information

Official study title

Ultrasound-guided Versus Landmark-based Spinal Anesthesia in Obese Parturients Undergoing Cesarean Section: a Prospective Comparative Study

Acronym: USLMCSEOB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Jul 7, 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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