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The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients

K

Karaman Training and Research Hospital

Status

Completed

Conditions

Morbid Obesity

Treatments

Procedure: Landmark group
Procedure: Ultrasound group

Study type

Interventional

Funder types

Other

Identifiers

NCT05342922
02-2022/02

Details and patient eligibility

About

This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section.

The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.

Full description

Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may have difficulties in determining the poorly palpable surface landmarks in morbidly obese pregnant women.

Manual palpation technique, which is preferred in neuraxial anesthesia, may be difficult in obese pregnant women due to the difficulty in identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease number of attempts in obese parturients.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. Patient, the anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups.Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 150 ultrasound-guided neuraxial blocks.

Enrollment

80 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Parturient who will receive selective cesarean delivery under spinal anesthesia
  • ASA 2-3 scheduled for elective sections
  • BMI≥40 kg/m2
  • normal singleton pregnancy
  • ≥37 weeks of gestation

Exclusion criteria

  • Multiple gestations
  • Emergency C-section
  • exist contraindications of spinal anesthesia
  • Local anesthetics allergy
  • BMI<40 kg/m2
  • history of lumbar spinal diseases and lumbar surgery
  • Parturient refusal

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Ultrasound group
Active Comparator group
Description:
Ultrasound assited technique will be used for spinal anesthesia performance.
Treatment:
Procedure: Ultrasound group
Landmark group
Experimental group
Description:
Land-mark assisted technique will be used for spinal anesthesia performance.
Treatment:
Procedure: Landmark group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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