Trial Outcomes & Findings for Lidocaine and Pain Management in First Trimester Abortions (NCT NCT00613821)

NCT ID: NCT00613821

Last Updated: 2017-07-31

Results Overview

Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Immediately (time zero) at uterine aspiration
• Results posted on: 2017-07-31

Participant Flow

Participant milestones

Measure	Lidocaine Infusion 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.	Paracervical Block Only Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Overall Study STARTED	40	40
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Lidocaine Infusion 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.	Paracervical Block Only Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	1

Baseline Characteristics

Lidocaine and Pain Management in First Trimester Abortions

Baseline characteristics by cohort

Measure	Lidocaine Infusion n=40 Participants 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.	Paracervical Block Only n=40 Participants Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.	Total n=80 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	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 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	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately (time zero) at uterine aspiration

Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).

Outcome measures

Measure	Lidocaine Infusion n=40 Participants 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.	Paracervical Block Only n=40 Participants Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.	71 mm Standard Deviation 20	43 mm Standard Deviation 30

Adverse Events

Lidocaine Infusion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Paracervical Block Only

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lidocaine Infusion n=40 participants at risk 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.	Paracervical Block Only n=40 participants at risk Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Reproductive system and breast disorders Immediate reaspiration	2.5% 1/40 • Number of events 1 • Adverse event data was collected at procedure visit and follow up visit, 2 weeks post-procedure.	0.00% 0/40 • Adverse event data was collected at procedure visit and follow up visit, 2 weeks post-procedure.
Reproductive system and breast disorders Needed antibiotics at follow up visit	0.00% 0/40 • Adverse event data was collected at procedure visit and follow up visit, 2 weeks post-procedure.	5.0% 2/40 • Number of events 2 • Adverse event data was collected at procedure visit and follow up visit, 2 weeks post-procedure.
Reproductive system and breast disorders Delayed reaspiration	0.00% 0/40 • Adverse event data was collected at procedure visit and follow up visit, 2 weeks post-procedure.	2.5% 1/40 • Number of events 1 • Adverse event data was collected at procedure visit and follow up visit, 2 weeks post-procedure.

Additional Information

Dr. Alison Edelman

Oregon Health & Science University

Phone: 503-494-3666

Email: whru@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place