Trial Outcomes & Findings for Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial (NCT NCT02447029)

Results Overview

This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

142 participants

Primary outcome timeframe

At time of cervical dilation, 30 minutes after lidocaine administration

Results posted on

2024-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Active Comparator Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Overall Study STARTED	72	70
Overall Study Treated	69	68
Overall Study COMPLETED	69	68
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Comparator Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection	Total n=137 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	69 Participants n=5 Participants	68 Participants n=7 Participants	137 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	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At time of cervical dilation, 30 minutes after lidocaine administration

Population: Treated participants were included in the analysis.

This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.

Outcome measures

Outcome measures
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale	68 units on a scale Interval 17.0 to 97.0	65 units on a scale Interval 10.0 to 100.0

SECONDARY outcome

Timeframe: Pain level prior to procedure

Population: Treated patients were included in the analysis

This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.

Outcome measures

Outcome measures
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale	59 units on a scale Interval 3.0 to 98.0	56 units on a scale Interval 12.0 to 99.0

SECONDARY outcome

Timeframe: Pain at time of speculum insertion

Population: Treated patients were included in the analysis

This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.

Outcome measures

Outcome measures
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Pain With Speculum Insertion as Measured by a Visual Analog Scale	19.5 units on a scale Standard Deviation 18.4	22.3 units on a scale Standard Deviation 19.5

SECONDARY outcome

Timeframe: Pain at time of tenaculum placement

Population: All treated patients were included in the analysis

This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.

Outcome measures

Outcome measures
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Pain With Tenaculum Placement as Measured by a Visual Analog Scale	39.8 units on a scale Standard Deviation 22.3	32.4 units on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: Pain prior to discharge home: 30-45 minutes after completion of procedure

Population: All treated patients were included in the analysis

This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.

Outcome measures

Outcome measures
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale	9 units on a scale Interval 0.0 to 85.0	11.5 units on a scale Interval 0.0 to 90.0

SECONDARY outcome

Timeframe: 30-45 minutes after completion of procedure

Population: All treated patients were included in the analysis

This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.

Outcome measures

Outcome measures
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Overall Satisfaction With Procedure as Measured by a Visual Analog Scale	86 units on a scale Interval 0.0 to 99.0	92.5 units on a scale Interval 44.0 to 100.0

SECONDARY outcome

Timeframe: Rate of complications at the end of the study

Population: All treated patients were analyzed

Outcome measures

Outcome measures
Measure	Active Comparator n=69 Participants Drug: vaginal 2% Xylocaine vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block	Standard Lidocaine Paracervical Block n=68 Participants standard lidocaine paracervical block standard lidocaine paracervical block: 1% lidocaine paracervical injection
Overall Complication Rate as Measured by a Count of Participants in Each Group	0 Participants	0 Participants

Adverse Events

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Lidocaine Paracervical Block

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

Principal Investigator

Stanford University

Phone: 650-497-5175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place