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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound group
Landmark group
Sponsored by
Karaman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Spinal Anesthesia, Cesarean Delivery, Ultrasound

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Karaman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ultrasound group

Landmark group

Arm Description

Ultrasound assited technique will be used for spinal anesthesia performance.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of skin punctures
Skin puncture is defined as any separate skin puncture attempt.
Number of needle pass
Needle pass is defined as skin puncture plus number of redirection attempts
The procedure duration time
The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow
Time interval to determine needle insertion site
Time interval between the operator touches the parturient and the completion of the needle insertion point marking
Time taken for spinal injection
The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.
Number of puncture levels
Move to a second lumbar space after 3 needle insertion attempts
Patient satisfaction The procedure duration
Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.
incidence of complications during puncture
Incidence of radicular pain, paresthesia, and blood during spinal needle injection
incidence of postoperative headache
12-72 hours following spinal anesthesia due to CSF leakage
Incidence of hypotension
A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg
Failure rate of spinal anesthesia
Number of parturients who need additional analgesic drug or conversion to general anesthesia
dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ]
thoracic dermatome level of sensory block assessed by pinprick test

Full Information

First Posted
April 18, 2022
Last Updated
January 24, 2023
Sponsor
Karaman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05342922
Brief Title
The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients
Official Title
Comparison of Ultrasound and Anatomical Land-mark Method in Spinal Anesthesia for Elective Cesarean Section in Obese Parturients With BMI ≥ 40 kg/m2. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
January 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Spinal Anesthesia, Cesarean Delivery, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant,Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound group
Arm Type
Active Comparator
Arm Description
Ultrasound assited technique will be used for spinal anesthesia performance.
Arm Title
Landmark group
Arm Type
Experimental
Arm Description
Land-mark assisted technique will be used for spinal anesthesia performance.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Landmark group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The success rate of first puncture
Description
Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.
Time Frame
30 minute
Secondary Outcome Measure Information:
Title
Number of skin punctures
Description
Skin puncture is defined as any separate skin puncture attempt.
Time Frame
30 minute
Title
Number of needle pass
Description
Needle pass is defined as skin puncture plus number of redirection attempts
Time Frame
30 minute
Title
The procedure duration time
Description
The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow
Time Frame
30 minute
Title
Time interval to determine needle insertion site
Description
Time interval between the operator touches the parturient and the completion of the needle insertion point marking
Time Frame
30 minute
Title
Time taken for spinal injection
Description
The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.
Time Frame
30 minute
Title
Number of puncture levels
Description
Move to a second lumbar space after 3 needle insertion attempts
Time Frame
30 minute
Title
Patient satisfaction The procedure duration
Description
Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.
Time Frame
30 minute
Title
incidence of complications during puncture
Description
Incidence of radicular pain, paresthesia, and blood during spinal needle injection
Time Frame
30 minute
Title
incidence of postoperative headache
Description
12-72 hours following spinal anesthesia due to CSF leakage
Time Frame
72 hour
Title
Incidence of hypotension
Description
A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg
Time Frame
2 hour
Title
Failure rate of spinal anesthesia
Description
Number of parturients who need additional analgesic drug or conversion to general anesthesia
Time Frame
120 minute
Title
dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ]
Description
thoracic dermatome level of sensory block assessed by pinprick test
Time Frame
20 minute

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study only includes pregnant patients who will deliver by elective cesarean section.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betul Basaran, MD,DESA
Organizational Affiliation
Karaman Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Karaman Training and Research Hospital
City
Karaman
ZIP/Postal Code
70200
Country
Turkey

12. IPD Sharing Statement

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

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