NCT05342922

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
Last Updated

January 25, 2023

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 18, 2022

Last Update Submit

January 24, 2023

Conditions

Morbid Obesity

Keywords

Spinal AnesthesiaCesarean DeliveryUltrasound

Outcome Measures

Primary Outcomes (1)

  • The success rate of first puncture

    Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.

    30 minute

Secondary Outcomes (12)

  • Number of skin punctures

    30 minute

  • Number of needle pass

    30 minute

  • The procedure duration time

    30 minute

  • Time interval to determine needle insertion site

    30 minute

  • Time taken for spinal injection

    30 minute

  • +7 more secondary outcomes

Study Arms (2)

Ultrasound group

ACTIVE COMPARATOR

Ultrasound assited technique will be used for spinal anesthesia performance.

Procedure: Ultrasound group

Landmark group

EXPERIMENTAL

Land-mark assisted technique will be used for spinal anesthesia performance.

Procedure: Landmark group

Interventions

Ultrasound groupPROCEDURE

In the operating room, all of the patients will receive standard monitoring. Scans will be made in logiditunal parasagittal and transverse midline views with ultrasound. Needle entry sites in the L2-L3 and L3-L4 intervals will be determined as the intersection of the longiditunal and transverse lines. When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.

Ultrasound group
Landmark groupPROCEDURE

In the Landmark group, the injection site will be determined using the traditional method of palpating the posterior superior iliac spine.When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.

Landmark group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study only includes pregnant patients who will deliver by elective cesarean section.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Betul Basaran, MD,DESA

    Karaman Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant,Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 25, 2022

Study Start

May 23, 2022

Primary Completion

January 23, 2023

Study Completion

January 24, 2023

Last Updated

January 25, 2023

Record last verified: 2022-04

Locations

TU(1)