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

Pain Clinical Trial

Official title:

3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03405311
• Other study ID #: 17-0286
• Status: Terminated
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: January 11, 2024

Study information

• Verified date: March 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Pain
• Pregnancy

Intervention

Device:
• Rivanna Accuro 3D Ultrasound Device
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device

Other:
• Palpation
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

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Beginning of needle insertion till catheter placement-15 minutes
Primary	Successful epidural catheter placement	Epidural failure-replacement will be recorded	Within first 90 minutes following catheter placement
Secondary	Procedural difficulty	Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).	Beginning of needle insertion till catheter placement-15 minutes
Secondary	Needle depth	We will also record thouy needle depth from skin and measured depth by ultrasound.	Beginning of needle insertion till catheter placement-15 minutes
Secondary	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).	Before epidural placement and hospital discharge up to 3 days
Secondary	Complications	Any complications related to the epidural will be recorded	Within 30 days of admission

External Links

•   510(k) clearance for the Rivanna Accuro ultrasound device