12 Versus 20 mL PCB for D&E Cervical Prep

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03356145
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Actual Duration (Months): 45.4
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: 12 mL paracervical block; Drug: 20 mL paracervical block	Phase 4

Detailed Description

This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
• Masking: Single (Participant)
• Masking Description: The provider and staff will be aware of arm allocation, but participants will remain blinded.
• Primary Purpose: Treatment
• Official Title: 12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Oct 15, 2020
• Actual Study Completion Date: Oct 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 12 mL arm Intervention: Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal needle 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix The tenaculum is immediately placed at the previously injected site The remaining 10 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal) No wait time between injection and dilator insertion	Drug: 12 mL paracervical block; Injection of 12 mL of lidocaine
Active Comparator: 20 mL arm Intervention: Syringe loaded with 20 mL of 1% lidocaine (120 mg); 22-gauge spinal needle 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix The tenaculum is immediately placed at the previously injected site The remaining 18 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal) No wait time between injection and dilator insertion	Drug: 20 mL paracervical block; Injection of 20 mL of lidocaine

Outcome Measures

Primary Outcome Measures

1. Pain Immediately Following Dilator Insertion [Time of dilator insertion (less than 1 minute to assess pain)]

   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).

Secondary Outcome Measures

1. Anticipated Pain Immediately Prior to Dilator Insertion [Up to 1 minute to complete survey]

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

2. Patient Global Satisfaction Score [Up to 1 minute to complete survey]

   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").

3. Total Procedure Time [Up to 10 minutes]

   Defined as time of speculum insertion

4. Physician-reported Ease of Insertion [Up to 1 minute to complete survey]

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

5. Count of Participants With Procedural Complications [Up to 10 minutes]

6. Count of Participants With Side Effects Related to Lidocaine Administration [Up to 10 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women 18 and older

• Intrauterine pregnancy ≥16 weeks gestation

• English speaking competency

• Willing and able to sign consent forms

• Agree to comply with study procedures

Exclusion Criteria:

• Women less than 18 years of age

• IV conscious sedation

• Known allergy to study medication (lidocaine)

• Any women not meeting inclusion criteria above will be excluded from participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Principal Investigator, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 24, 2018

More Information

Publications

None provided.

• Responsible Party: Kate Ayers Shaw, Clinical Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03356145
• Other Study ID Numbers: IRB-43789
• First Posted: Nov 29, 2017
• Last Update Posted: Oct 19, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Kate Ayers Shaw, Clinical Associate Professor, Stanford University: paracervical block; abortion; dilation and evacuation; cervical preparation

Study Results

Participant Flow

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Period Title: Overall Study
STARTED	48	48
Received Allocated Intervention	45	47
COMPLETED	45	47
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	12 mL Arm	20 mL Arm	Total
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.	Total of all reporting groups
Overall Participants	45	46	91
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (7)	31 (7)	31 (7.8)
Sex: Female, Male (Count of Participants)
Female	45 100%	46 100%	91 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 20%	16 34.8%	25 27.5%
Not Hispanic or Latino	36 80%	30 65.2%	66 72.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	18 40%	15 32.6%	33 36.3%
Native Hawaiian or Other Pacific Islander	0 0%	1 2.2%	1 1.1%
Black or African American	0 0%	0 0%	0 0%
White	27 60%	29 63%	56 61.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 2.2%	1 1.1%
Region of Enrollment (Count of Participants)
United States	45 100%	46 100%	91 100%

Outcome Measures

1. Primary Outcome

Title	Pain Immediately Following Dilator Insertion
Description	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).
Time Frame	Time of dilator insertion (less than 1 minute to assess pain)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Measure Participants	45	46
Median (Inter-Quartile Range) [score on a scale]	41	49

2. Secondary Outcome

Title	Anticipated Pain Immediately Prior to Dilator Insertion
Description	Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).
Time Frame	Up to 1 minute to complete survey

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Measure Participants	45	46
Median (Inter-Quartile Range) [score on a scale]	51	58

3. Secondary Outcome

Title	Patient Global Satisfaction Score
Description	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").
Time Frame	Up to 1 minute to complete survey

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Measure Participants	45	46
Median (Inter-Quartile Range) [score on a scale]	70	53

4. Secondary Outcome

Title	Total Procedure Time
Description	Defined as time of speculum insertion
Time Frame	Up to 10 minutes

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Measure Participants	45	46
Median (Inter-Quartile Range) [minutes]	5.5	5.7

5. Secondary Outcome

Title	Physician-reported Ease of Insertion
Description	Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").
Time Frame	Up to 1 minute to complete survey

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Measure Participants	45	46
Median (Inter-Quartile Range) [score on a scale]	27	17

6. Secondary Outcome

Title	Count of Participants With Procedural Complications
Time Frame	Up to 10 minutes

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Measure Participants	45	46
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Count of Participants With Side Effects Related to Lidocaine Administration
Description	Side effects were not necessarily considered to be adverse events by investigator.
Time Frame	Up to 10 minutes

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	12 mL Arm	20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.	Participants receive injection of 20 mL of lidocaine.
Measure Participants	45	46
Metallic taste	2 4.4%	3 6.5%
Ringing in ears	2 4.4%	3 6.5%
Dizziness or lightheadedness	1 2.2%	6 13%
Shaky legs	0 0%	1 2.2%

Adverse Events

Time Frame	Average approximately 45 minutes
Arm/Group Title	12 mL Arm		20 mL Arm
Arm/Group Description	Participants receive injection of 12 mL of lidocaine.		Participants receive injection of 20 mL of lidocaine.
All Cause Mortality
	12 mL Arm		20 mL Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Serious Adverse Events
	12 mL Arm		20 mL Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	12 mL Arm		20 mL Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.