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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07549776
Acronym
USLMCSEOB
Enrollment
100
Registered
2026-04-24
Start date
2025-07-01
Completion date
2026-01-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Obesity

Keywords

Ultrasonography, Spinal anesthesia, Cesarean section, Obesity, Neuraxial anesthesia

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREUltrasound-guided preprocedural marking

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

PROCEDURELandmark-based palpation

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

Sponsors

Instituto Nacional Materno Perinatal, Peru
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Due to the nature of the intervention, blinding of the operators was not feasible.

Intervention model description

Participants were prospectively allocated to one of two comparison groups according to the puncture site localization technique (preprocedural ultrasound marking or anatomical landmark palpation) before spinal anesthesia.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
First-attempt success rate of spinal anesthesiaDuring the spinal anesthesia procedureSuccessful cerebrospinal fluid return after the first needle insertion without redirection.

Secondary

MeasureTime frameDescription
Number of puncture attemptsDuring the spinal anesthesia procedureTotal number of needle insertions required to achieve successful spinal anesthesia
Number of needle redirectionsDuring the spinal anesthesia procedureNumber of needle redirections during a single puncture attempt
Need for rescue interventionDuring the spinal anesthesia procedureRequirement of assistance by a more experienced operator to complete the procedure
Incidence of paresthesiaDuring the spinal anesthesia procedureOccurrence of paresthesia during needle insertion
Incidence of vascular punctureDuring the spinal anesthesia procedureOccurrence of vascular puncture during needle insertion
Total procedure timeDuring the spinal anesthesia procedureTime from initial identification of the puncture site to successful cerebrospinal fluid return
Puncture timeDuring the spinal anesthesia procedureTime from needle insertion to successful cerebrospinal fluid return

Countries

Peru

Contacts

PRINCIPAL_INVESTIGATOREddisson R Quispe Pilco, MD

National Maternal and Perinatal Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026