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3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient

Primary Purpose

Obesity, Morbid, Pregnancy, Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rivanna Accuro 3D Ultrasound Device
Palpation
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Labor analgesia, Ultrasound, Obesity, Morbid, Pregnancy, Labor Epidural Analgesia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists physical status class I, II, or III.
  • Term pregnancy.
  • Requesting epidural analgesia for anticipated vaginal delivery.
  • BMI>or = 40.

Exclusion Criteria:

  • Contraindication for epidural analgesia
  • Inability to adequately understand the consent form.
  • Incarcerated patients.
  • Patients with known spinal deformities.
  • Allergies to ultrasound gel.
  • Allergies to local anesthetics

Sites / Locations

  • The University of Texas Medical BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Palpation

Rivanna Accuro 3D Ultrasound Device

Arm Description

The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.

The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.

Outcomes

Primary Outcome Measures

Number of needle insertion attempts and redirections
An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt
Successful epidural catheter placement
Epidural failure-replacement will be recorded

Secondary Outcome Measures

Procedural difficulty
Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).
Needle depth
We will also record thouy needle depth from skin and measured depth by ultrasound.
Pressure pain thresholds and pain scores
Pressure pain thresholds will be obtained immediately prior to the epidural placement. The force that the patient will be indicated uncomfortable will be recorded. Each intervertebral level will be measured once. The PPT will be measured the next day after the discontinuation of the epidural.Twenty-four hours post-partum, pain with analgesia during labor was assessed using the Numerical Rating Scale (NRS).
Complications
Any complications related to the epidural will be recorded

Full Information

First Posted
January 2, 2018
Last Updated
March 10, 2023
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03405311
Brief Title
3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
Official Title
3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device).
Detailed Description
Worldwide obesity has become an epidemic. The obstetrical population is no exception. This made more challenging for anesthesiologists on labor and delivery units to administer epidural analgesia. According to the World Health Organization, more than 30% of U.S. adults are obese with a body mass index (BMI; in kg/m2) ≥ 30. Recent data has shown that increased BMI has been associated with increased neuraxial analgesic failure and difficulty with prolonged epidural placement time. The 'Blind approach' is the current standard of care in administering neuraxial anesthesia. The physician palpates the patient's spinal bony landmarks; the needle is placed in relation to identified landmarks and inserted until loss of resistance is felt. In the obese population, the success rates are as low as 68%. Recently the FDA has approved a handheld device "The Accuro" as an adjunct for neuraxial analgesia (Rivanna Medical, LLC). It consists of a three-dimensional ultrasound device. By utilizing sound waves it constructs three-dimensional images of the spinal column, allowing the physician to better see the spine in order to perform spinal/epidural anesthesia. Hypothesize that this device will enable clinicians to assess epidural spaces for epidural needle placement compared with the traditional Blind approach in the morbidly obese parturient. This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device). Also, will determine if ultrasound based landmarks would reduce the needle tract and thereby reduced the amount of post-procedure pain at the insertion site in the peripartum period by using the algometer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Pregnancy, Pain
Keywords
Labor analgesia, Ultrasound, Obesity, Morbid, Pregnancy, Labor Epidural Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palpation
Arm Type
Active Comparator
Arm Description
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Arm Title
Rivanna Accuro 3D Ultrasound Device
Arm Type
Experimental
Arm Description
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Intervention Type
Device
Intervention Name(s)
Rivanna Accuro 3D Ultrasound Device
Intervention Description
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
Intervention Type
Other
Intervention Name(s)
Palpation
Intervention Description
The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
Primary Outcome Measure Information:
Title
Number of needle insertion attempts and redirections
Description
An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt
Time Frame
Beginning of needle insertion till catheter placement-15 minutes
Title
Successful epidural catheter placement
Description
Epidural failure-replacement will be recorded
Time Frame
Within first 90 minutes following catheter placement
Secondary Outcome Measure Information:
Title
Procedural difficulty
Description
Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).
Time Frame
Beginning of needle insertion till catheter placement-15 minutes
Title
Needle depth
Description
We will also record thouy needle depth from skin and measured depth by ultrasound.
Time Frame
Beginning of needle insertion till catheter placement-15 minutes
Title
Pressure pain thresholds and pain scores
Description
Pressure pain thresholds will be obtained immediately prior to the epidural placement. The force that the patient will be indicated uncomfortable will be recorded. Each intervertebral level will be measured once. The PPT will be measured the next day after the discontinuation of the epidural.Twenty-four hours post-partum, pain with analgesia during labor was assessed using the Numerical Rating Scale (NRS).
Time Frame
Before epidural placement and hospital discharge up to 3 days
Title
Complications
Description
Any complications related to the epidural will be recorded
Time Frame
Within 30 days of admission

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status class I, II, or III. Term pregnancy. Requesting epidural analgesia for anticipated vaginal delivery. BMI>or = 40. Exclusion Criteria: Contraindication for epidural analgesia Inability to adequately understand the consent form. Incarcerated patients. Patients with known spinal deformities. Allergies to ultrasound gel. Allergies to local anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rovnat Babazade, MD
Phone
2164826696
Email
robabaza@utmb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rovnat Babazade, MD
Organizational Affiliation
The University of Texas Medical Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rovnat Babazade, MD

12. IPD Sharing Statement

Links:
URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132736
Description
510(k) clearance for the Rivanna Accuro ultrasound device

Learn more about this trial

3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient

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