Identification of L3-L4 Interspace in Parturients

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02697747
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Duration (Months): 69
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4 interspace will improve resident's long term skill to correctly identify the interspace as compared to palpation alone.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Education

Detailed Description

This will be an observational education based study to improve anesthesiology resident's ability to correctly identify the L3-L4 interspace. Residents who agree to participate in the study will be trained using ultrasound to identify the L3-L4 interspace during their rotation on the obstetric anesthesia service. Training will include using the ultrasound to correlate the surface palpation with the underlying structures. This will be supplemented with teaching videos and literature. The training will be performed for the first three weeks of the four week rotation.

After undergoing this training program, during the fourth week of the rotation, the residents will be asked to perform palpation identification of the L3-L4 interspace on parturients. Ultrasound will be used to assess the accuracy of the identified level. These assessments will repeated at six and 12 months to assess whether the skill has been retained.

Study Design

• Study Type: Observational
• Actual Enrollment: 18 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Identification of L3-L4 Interspace in Parturients
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Ultrasound education Training in the use of ultrasound to identify the L3-L4 interspace	Other: Education; Educational intervention in the use of ultrasound to identify landmarks

Outcome Measures

Primary Outcome Measures

1. Accuracy measured as percentage of cases where the L3-4 vertebral interspace is identified correctly [1 month]

   Percentage of cases where the L3-4 vertebral interspace is identified correctly

Secondary Outcome Measures

1. Durability measured as percentage of cases where the L3-4 vertebral interspace is identified correctly [6 months and 12 months]

   percentage of cases where the L3-4 interspace is identified correctly at 6 months and again at 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• term gestation (at least 38 weeks gestation)

Exclusion Criteria:

• Prior back surgery

• Previously diagnosed skeletal deformities such as scoliosis

• BMI greater than 40

• Height less than 60 inches

• Patient discomfort requiring immediate analgesia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Philip E Hess, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phillip Hess, Staff Anesthesiologist, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT02697747
• Other Study ID Numbers: 2015P000225
• First Posted: Mar 3, 2016
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Phillip Hess, Staff Anesthesiologist, Beth Israel Deaconess Medical Center: Ultrasound; Palpation; Analgesia; Epidural

Study Results

No Results Posted as of Oct 1, 2021