Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Labor Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only males
Description
This randomized prospective clinical trial aims to evaluate timing savings in performing labor epidural analgesia and the success rate of labor analgesia with and without the guidance of a handheld ultrasound device in various BMI groups. In routine clinical setting, patients admitted to clinic and ...
This randomized prospective clinical trial aims to evaluate timing savings in performing labor epidural analgesia and the success rate of labor analgesia with and without the guidance of a handheld ultrasound device in various BMI groups. In routine clinical setting, patients admitted to clinic and evaluated labor condition. If patient in active labor and request epidural for labor pain, the standard care team inform obstetric anesthesia epidural team by using pager. Standard of care anesthesia epidural team perform preoperative evaluation and placed the catheter. The patients in active labor will receive labor epidural analgesia, regardless of the study participation. There is no changes epidural local anesthetic type and doses. The research intervention is only placing hand-hold ultrasound to the back of the patient and see the land mark visually before the epidural catheter placement. The remaining catheter placement is the same as the control group. Study Procedures: A Total of 300 eligible parturients will be randomly assigned to one of the two groups either the ultrasound imaging guidance or the traditional landmark palpation group for labor epidural needle placement. The research intervention is simply placing a hand-held ultrasound device on the back of the patient and insert the epidural needle with ultrasound image guidance. Parturient will receive epidural catheter regardless of the study participation. In the traditional landmark method, anesthetist palpates the structure to determine the site of the initial needle insertion site. The needle will be protruded as in usual standard practice. Anesthetist may remove and insert needle again until feeling epidural space. When anesthetist determine the tip of the needle is in the epidural space, the epidural catheter will be protruded through the needle.
Tracking Information
- NCT #
- NCT04020042
- Collaborators
- Not Provided
- Investigators
- Study Director: Seema Dave, MPH UT Southwestern Medical Center