Trial Outcomes & Findings for 12 Versus 20 mL PCB for D&E Cervical Prep (NCT NCT03356145)

NCT ID: NCT03356145

Last Updated: 2024-01-23

Results Overview

The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 96 participants
• Primary outcome timeframe: Time of dilator insertion (less than 1 minute to assess pain)
• Results posted on: 2024-01-23

Participant Flow

Participant milestones

Measure	12 mL Arm Participants receive injection of 12 mL of lidocaine.	20 mL Arm Participants receive injection of 20 mL of lidocaine.
Overall Study STARTED	48	48
Overall Study Received Allocated Intervention	45	47
Overall Study COMPLETED	45	47
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	12 mL Arm Participants receive injection of 12 mL of lidocaine.	20 mL Arm Participants receive injection of 20 mL of lidocaine.
Overall Study Withdrawal by Subject	2	1
Overall Study Did not meet inclusion criteria	1	0

Baseline Characteristics

12 Versus 20 mL PCB for D&E Cervical Prep

Baseline characteristics by cohort

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.	Total n=91 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 7 • n=5 Participants	31 years STANDARD_DEVIATION 7 • n=7 Participants	31 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	30 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time of dilator insertion (less than 1 minute to assess pain)

Population: Participants who received the allocated intervention and for whom primary outcome data are available

The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).

Outcome measures

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.
Pain Immediately Following Dilator Insertion	41 score on a scale Interval 21.0 to 58.0	49 score on a scale Interval 26.0 to 65.0

SECONDARY outcome

Timeframe: Up to 1 minute to complete survey

Population: Participants who received the allocated intervention and for whom primary outcome data are available

Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).

Outcome measures

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.
Anticipated Pain Immediately Prior to Dilator Insertion	51 score on a scale Interval 28.0 to 62.0	58 score on a scale Interval 43.0 to 69.0

SECONDARY outcome

Timeframe: Up to 1 minute to complete survey

Population: Participants who received the allocated intervention and for whom primary outcome data are available

Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 ("worse than expected"), 50 ("what I expected"), and 100 ("better than expected").

Outcome measures

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.
Patient Global Satisfaction Score	70 score on a scale Interval 39.0 to 91.0	53 score on a scale Interval 44.0 to 87.0

SECONDARY outcome

Timeframe: Up to 10 minutes

Population: Participants who received the allocated intervention and for whom primary outcome data are available

Defined as time of speculum insertion

Outcome measures

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.
Total Procedure Time	5.5 minutes Interval 4.6 to 6.9	5.7 minutes Interval 4.6 to 7.2

SECONDARY outcome

Timeframe: Up to 1 minute to complete survey

Population: Participants who received the allocated intervention and for whom primary outcome data are available

Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").

Outcome measures

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.
Physician-reported Ease of Insertion	27 score on a scale Interval 13.0 to 50.0	17 score on a scale Interval 6.0 to 28.0

SECONDARY outcome

Timeframe: Up to 10 minutes

Population: Participants who received the allocated intervention and for whom primary outcome data are available

Outcome measures

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.
Count of Participants With Procedural Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 10 minutes

Population: Participants who received the allocated intervention and for whom primary outcome data are available

Side effects were not necessarily considered to be adverse events by investigator.

Outcome measures

Measure	12 mL Arm n=45 Participants Participants receive injection of 12 mL of lidocaine.	20 mL Arm n=46 Participants Participants receive injection of 20 mL of lidocaine.
Count of Participants With Side Effects Related to Lidocaine Administration Metallic taste	2 Participants	3 Participants
Count of Participants With Side Effects Related to Lidocaine Administration Ringing in ears	2 Participants	3 Participants
Count of Participants With Side Effects Related to Lidocaine Administration Dizziness or lightheadedness	1 Participants	6 Participants
Count of Participants With Side Effects Related to Lidocaine Administration Shaky legs	0 Participants	1 Participants

Adverse Events

12 mL Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

20 mL Arm

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: gynresearch@stanford.edu

Results disclosure agreements

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