Trial Outcomes & Findings for Local Anesthesia and Pain Perception During an Amniocentesis (NCT NCT00583011)

Results Overview

Visual Analogue Scale (Perpendicular line is drawn at the point that represents pain on a 0-100mm scale, with lower number meaning less pain and the higher number meaning more pain)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

Immediately following amniocentesis procedure

Results posted on

2021-02-03

Participant Flow

Assessed for eligibility (n=203) Excluded=127(26 not meeting inclusion criteria, 101 declined to participate)

Participant milestones

Participant milestones
Measure	Lidocaine Local anesthesia group Local anesthesia - lidocaine: Local anesthesia: 2 cc of 1% Lidocaine	Placebo Placebo normal saline group Placebo Group: Placebo Group: 2cc Normal Saline
Overall Study STARTED	36	40
Overall Study COMPLETED	36	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Local Anesthesia and Pain Perception During an Amniocentesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=36 Participants Lidocaine group 2cc of 1% lidocaine	Placebo n=40 Participants Normal saline group 2cc of normal saline	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.3 years STANDARD_DEVIATION 6.5 • n=5 Participants	30.1 years STANDARD_DEVIATION 7.5 • n=7 Participants	30.7 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	40 Participants n=7 Participants	76 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	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following amniocentesis procedure

Visual Analogue Scale (Perpendicular line is drawn at the point that represents pain on a 0-100mm scale, with lower number meaning less pain and the higher number meaning more pain)

Outcome measures

Outcome measures
Measure	Lidocaine n=36 Participants Lidocaine 2cc of 1% lidocaine group	Placebo n=40 Participants 2cc of Normal Saline group
Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)	9.5 units on a scale Interval 2.1 to 21.0	18.4 units on a scale Interval 12.9 to 31.3

SECONDARY outcome

Timeframe: Immediately following amniocentesis procedure

101 Point Numerical Rating Scale (NRS-101) (Choose a number that best described pain from 0 to 100 with 0 being least amount of pain and 100 being the worst pain)

Outcome measures

Outcome measures
Measure	Lidocaine n=36 Participants Lidocaine 2cc of 1% lidocaine group	Placebo n=40 Participants 2cc of Normal Saline group
Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)	15.4 units on a scale Standard Deviation 13.5	22.4 units on a scale Standard Deviation 19.8

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Andrew Elimian, MD

University of Oklahoma Health Science Center

Phone: 9142317323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place