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Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients

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ClinicalTrials.gov Identifier: NCT02747238
Recruitment Status : Terminated (lack of enrollment)
First Posted : April 21, 2016
Results First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Barbara S Orlando, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Pregnancy
Interventions Device: Ultrasound
Procedure: No ultrasound
Procedure: Epidural infusion
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ultrasound No Ultrasound
Hide Arm/Group Description

Patients that had Ultrasound guided CSE placed

Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.

Epidural infusion: An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups

Patients that had CSE placed using palpation of anatomical landmarks

No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia

Epidural infusion: An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups

Period Title: Overall Study
Started 12 20
Completed 9 14
Not Completed 3 6
Reason Not Completed
Lack of Efficacy             0             1
Data lost             3             5
Arm/Group Title Ultrasound No Ultrasound Total
Hide Arm/Group Description

Ultrasound guided CSE placed

Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

CSE placed using palpation of anatomical landmarks

No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

Total of all reporting groups
Overall Number of Baseline Participants 9 14 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
21 years and over Number Analyzed 9 participants 14 participants 23 participants
9
 100.0%
14
 100.0%
23
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 14 participants 23 participants
Female
9
 100.0%
14
 100.0%
23
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Learning Curve of Anesthesia Residents
Hide Description The success rate of epidural with each technique and improvement
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Ultrasound No Ultrasound
Hide Arm/Group Description:

Ultrasound guided CSE placed

Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

CSE placed using palpation of anatomical landmarks

No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Attempts
Hide Description The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound No Ultrasound
Hide Arm/Group Description:

Ultrasound guided CSE placed

Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

CSE placed using palpation of anatomical landmarks

No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

Overall Number of Participants Analyzed 9 14
Mean (Full Range)
Unit of Measure: attempts
1.333
(1 to 2)
1.357
(1 to 3)
3.Secondary Outcome
Title Percentage of Accurate Epidural Placement
Hide Description Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound No Ultrasound
Hide Arm/Group Description:

Ultrasound guided CSE placed

Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

CSE placed using palpation of anatomical landmarks

No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

Overall Number of Participants Analyzed 9 14
Measure Type: Number
Unit of Measure: percentage of accurate placement
66 86
4.Secondary Outcome
Title Number of Angle Adjustments in Space
Hide Description The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound No Ultrasound
Hide Arm/Group Description:

Ultrasound guided CSE placed

Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

CSE placed using palpation of anatomical landmarks

No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

Overall Number of Participants Analyzed 9 14
Mean (Full Range)
Unit of Measure: adjustments
1.78
(1 to 4)
1.28
(1 to 4)
Time Frame 1 Day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ultrasound No Ultrasound
Hide Arm/Group Description

Ultrasound guided CSE placed

Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

CSE placed using palpation of anatomical landmarks

No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia

Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc

All-Cause Mortality
Ultrasound No Ultrasound
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/14 (0.00%) 
Hide Serious Adverse Events
Ultrasound No Ultrasound
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ultrasound No Ultrasound
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Barbara Orlando
Organization: Icahn School of Medicine at Mount Sinai
Phone: 917-496-7490
EMail: barbara.orlando@mountsinai.org
Layout table for additonal information
Responsible Party: Barbara S Orlando, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02747238    
Other Study ID Numbers: GCO 15-1180
First Submitted: June 3, 2015
First Posted: April 21, 2016
Results First Submitted: February 24, 2021
Results First Posted: April 15, 2021
Last Update Posted: April 15, 2021