Trial Outcomes & Findings for Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients (NCT NCT02747238)

Results Overview

The success rate of epidural with each technique and improvement

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

1 month

Results posted on

2021-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasound 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	No Ultrasound 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
Overall Study STARTED	12	20
Overall Study COMPLETED	9	14
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ultrasound 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	No Ultrasound 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
Overall Study Lack of Efficacy	0	1
Overall Study Data lost	3	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound n=9 Participants 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	No Ultrasound n=14 Participants 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 n=23 Participants Total of all reporting groups
Age, Customized 21 years and over	9 Participants n=9 Participants	14 Participants n=14 Participants	23 Participants n=23 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	14 Participants n=14 Participants	23 Participants n=23 Participants
Sex: Female, Male Male	0 Participants n=9 Participants	0 Participants n=14 Participants	0 Participants n=23 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1 month

Population: Data not collected

The success rate of epidural with each technique and improvement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 minutes

The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.

Outcome measures

Outcome measures
Measure	Ultrasound n=9 Participants 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	No Ultrasound n=14 Participants 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
Number of Attempts	1.333 attempts Interval 1.0 to 2.0	1.357 attempts Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 2 hours

Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed

Outcome measures

Outcome measures
Measure	Ultrasound n=9 Participants 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	No Ultrasound n=14 Participants 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
Percentage of Accurate Epidural Placement	66 percentage of accurate placement	86 percentage of accurate placement

SECONDARY outcome

Timeframe: 30 minutes

The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.

Outcome measures

Outcome measures
Measure	Ultrasound n=9 Participants 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	No Ultrasound n=14 Participants 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
Number of Angle Adjustments in Space	1.78 adjustments Interval 1.0 to 4.0	1.28 adjustments Interval 1.0 to 4.0

Adverse Events

Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barbara Orlando

Icahn School of Medicine at Mount Sinai

Phone: 917-496-7490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place