Trial Outcomes & Findings for Does Ultrasound Help With Placement of Labor Analgesia in Pregnant Patients? (NCT NCT02207972)

Results Overview

Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

2 hours

Results posted on

2018-02-13

Participant Flow

Patients in labor requesting epidural will be offered to participate in the study for their neuraxial placement

Once the patient agrees to be in the study, they will be randomized into one of the 2 arms (with or without ultrasound) for their neuraxial placement.

Participant milestones

Participant milestones
Measure	Use of Ultrasound Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml Use of 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.	No Ultrasound Used Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia
Overall Study STARTED	22	24
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Ultrasound Help With Placement of Labor Analgesia in Pregnant Patients?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Use of Ultrasound n=22 Participants Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml Use of 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.	No Ultrasound Used n=24 Participants Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia	Total n=46 Participants Total of all reporting groups
Age, Continuous	31.83 years n=5 Participants	31.85 years n=7 Participants	31.84 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position

Outcome measures

Outcome measures
Measure	Use of Ultrasound n=22 Participants Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes	No Ultrasound Used n=24 Participants Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia
Number of Participants With Accurate Epidural Placement	21 Participants	23 Participants

SECONDARY outcome

Timeframe: Immediate

Population: Pregnant patients in labor requesting neuraxial analgesia

The number of participants who had first attempt success to locate the epidural space and midline position

Outcome measures

Outcome measures
Measure	Use of Ultrasound n=22 Participants Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes	No Ultrasound Used n=24 Participants Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia
Number of Participants With Successful First Attempt	19 Participants	21 Participants

SECONDARY outcome

Timeframe: immediate

the number of participants with successes without any readjustment of the angle in the space

Outcome measures

Outcome measures
Measure	Use of Ultrasound n=22 Participants Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes	No Ultrasound Used n=24 Participants Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia
Number of Participants Without Angle Adjustments in Space Success	16 Participants	12 Participants

Adverse Events

Use of Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Ultrasound Used

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 MD and PI

Mount Sinai West

Phone: 2125236915

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place