Clinical trial NCT02852434
Conditions: Pain Management, Cervical Preparation
Sponsor: Stanford University
Start date: 2016-07-01; Completion date: 2017-04-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D\&E) to paracervical block.

Detailed description:

Arms: arm 1: Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure arm 2: Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Interventions: intervention 1: Lidocaine Gel (2%) intervention 2: Lidocaine Paracervical Block (1%)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
Self-administered lidocaine gel for pain-control 
during cervical preparation for dilation and 
evacuation: A randomized controlled trial 
NCT02852434 
07/18/2016 
Stanford University 
Stanford, California 94305 
 


Self-administered lidocaine gel for pain-control during cervical preparation 
for dilation and evacuation: A randomized controlled trial 
 
Background 
Methods of cervical preparation prior to dilation and evacuation (D&E) after 16 
weeks gestation vary. Most commonly, providers in the United States use 
misoprostol, mifepristone, osmotic dilators, and laminaria—either independently 
or in conjunction with each other. Efforts to research the use of mifepristone and 
misoprostol alone for cervical preparation are motivated by the desire to 
decrease discomfort associated with cervical preparation and increase access to 
abortion at later gestations by eliminating the use of laminaria or osmotic dilators. 
To compliment these efforts, more research is needed to investigate methods of 
pain control for cervical preparation with osmotic dilators and laminaria to 
decrease patient discomfort. Women report laminaria and osmotic dilator 
placement to be painful.  
 
Pain control trials in the abortion literature often focus on pain with the abortion 
procedure itself. Those studies that report on pain with osmotic dilators show that 
insertion is painful. Few studies have focused on the methods of pain control for 
laminaria or osmotic dilator insertion alone. A recent study showed that 
paracervical block reduced pain with osmotic dilator insertion compared to a 
sham block [Soon R, et al abstract SFP). Self-administered lidocaine gel is a 
method of pain control found to be no worse than a paracervical block for pain 
control during surgical abortion at gestations of less than 12 weeks. We 
hypothesize that self-administered lidocaine gel is no worse than paracervical 
block for pain control with cervical preparation.  
 
This study seeks to compare self-administered lidocaine gel for pain control 
during cervical preparation (laminaria and/or osmotic dilator insertion) for D&E to 
paracervical block.  
 
Objectives 
 
Primary Objective 
Pain perceived at the time of dilator insertion measured by Visual Analogue 
Scale (VAS) (0-100mm).  
Secondary Objectives 
 Pain perceived at additional time points before, during, and after the 
procedure (all measured by VAS (0-100mm): 
o Anticipated Pain: 30 minutes prior to procedure 
o Baseline Pain: Immediately prior to procedure 
o Dilator Insertion: Immediately following dilator insertion 
o Post-Procedure Pain: 10-15 minutes following procedure 
o Overall Pain: Assessed after procedure 
 Incidence of complications 
 Provider reported ease of insertion 


 Global satisfaction (acceptability) of procedure 
 
Study Drugs 
 
Experimental Group: 
Xylocaine (lidocaine HCl) is a common local anesthetic that works by stabilizing 
the neuronal membrane by inhibiting the ionic fluxes required for the initiation 
and conduction of impulses. Local anesthetics of the amide type are thought to 
act within the sodium channels of the nerve membrane. According to the 
packaging insert, anesthesia is achieved within 5 minutes, depending on the area 
of application, and duration of anesthesia is approximately 20-30 minutes.  It is 
used prior to many genitourinary procedures involving mucus membranes 
including the urethra, anus, and vulva. While no recommended dose is known for 
vaginal use prior to surgical abortion, recommended doses are known for the 
following procedures: 20 ml for proctoscopy/anoscopy; 10 ml for female urethral 
anesthesia as in cystoscopy. A single maximum dosage for 2% Xylocaine jelly is 
not established [Blanco 1982], however Lexicomp drug information for topical 
lidocaine jelly cites a maximum dose of 600 mg in any 12-hour period. 
 
The serum toxicity of intracervical lidocaine is thought to be around 5 ug/ml 
[Blanco 1982] and a study looking at serum lidocaine levels 10 minutes after 
paracervical injection of 20 ml of 1% lidocaine (200 mg total) found mean blood 
levels of 0.9 to 1.61 ug/ml [McKenzie 1978].   
 
Similarly, a study investigating vaginal anesthesia with 4ml of 10% lidocaine 
spray (400mg total) 5 minutes prior to high dose intracavitary brachytherapy 
found a significant decrease in procedural pain [Chen 1998]. This study also 
looked at serum lidocaine levels at various time points following administration 
and found that the 400mg dose never reached toxic levels in participants. These 
data are further supported by non-toxic levels seen after nasopharyngeal and 
oropharyngeal application in the studies sited above. 
 
Based on this information, participants in the lidocaine gel group will self-
administer 20 ml of 2% lidocaine HCl vaginally (400 mg total) 20-30 minutes prior 
to the start of the procedure. We are allowing a window of time to account for real 
life clinic practice and possible delays. 
 
 The product: 
 XYLOCAINE® JELLY 2% (lidocaine hydrochloride) AstraZeneca 
o 20 mL (20 mg/mL) – 400mg total 
 
Control Group: 
Paracervical block technique: 
 Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal 
needle (x mg total) 


 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 (1-2 cm) to superficial (injecting with insertion and 
withdrawal) 
 
Study Population 
Women presenting for abortion ≥16 weeks gestation will be invited to participate 
in the study protocol. This population was selected, as they typically require more 
dilators than the patients at lower gestational ages.  
 
Explanation of Sample Size 
Studies of patient reported pain scores indicate that the minimum, significant 
difference in pain score on a 100mm Visual Analogue Scale (VAS) is 13-16mm. 
Studies of laminaria insertion document pain scores ranging from 43-70mm, with 
standard deviation of 22-23. We determined Considering the continuous primary 
outcome and our non-inferiority hypothesis, if there is truly no difference between 
paracervical block and self-administered lidocaine gel for pain control with 
cervical preparation for D&E after 16 weeks gestation, 68 participants are 
required to be 80% sure that the lower limit of a one-sided 97.5% confidence 
interval (or equivalently a 95% two-sided confidence interval) will be above the 
non-inferiority limit of 15mm. Accounting for participant drop-out, we will recruit 
72 women to participate in this study (significance level, alpha of 2.5%; power of 
80%; standard deviation of 22; non-inferiority limit of 15).  
 
Overview of Study Design 
 
Recruitment and Allocation of Subjects 
Subjects will be recruited from the Stanford Gynecology Clinic in Palo Alto, 
California. They will be identified for participation through prospective chart 
review. Informed consent will be obtained from a trained research coordinator. 
Upon agreeing to participant, subjects will be randomized through block 
randomization to a study arm.  
 
Criteria for Subject Selection 
Inclusion: 
 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: 
 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 
 
Study Procedures 
This study will take place during subjects’ cervical preparation visit. Following 
informed consent, participants will be randomized to a study group—group 
allocation information will be kept in a sealed, opaque envelope. Upon 
consenting for the study, a research coordinator will assign a unique subject ID 
number to the participant. This subject ID number’s envelope will be opened to 
determine allocation. Participants, research staff, and health care provider will 
not be blinded to the allocation.   
 
If the subject is randomized to the experimental group (self-administered 
lidocaine gel), she will be instructed on how to self-administer the gel vaginally by 
the study coordinator. She will insert 20ml of 2% lidocaine gel into her vagina 
using a pre-loaded syringe. After 15 minutes, the procedure will be begin. 
 
If the subject is randomized to the control group (provider-administered 
paracervical block), cervical anesthesia and preparation will commence to 
standard.  
 
For both groups, the research coordinator will collect demographic and medical 
history and document procedure data. For VAS scores, the research coordinator 
will administer the 100mm VAS on an iPad. Pain scores will taken “in real time”. 
There is no follow-up for this study.  
 
Data Collection 
Data collection will be obtained through a REDCap survey.  
 
Data to be collected include: 
 Demographics 
o Location of procedure 
o MRN 
o Date enrolled 
o First name 
o Last name 
o Date of birth 
o Age 
o Phone number 
o Race 
o Ethnicity 
 Medical History (Physical Exam and Ob/Gyn History) 
o Height 
o Weight 


o BMI 
o Gestational age 
o Medication allergies 
o Current medications 
o Number of previous pregnancies 
 Number of previous vaginal deliveries 
 Number of previous cesarean sections 
 Number of previous abortions 
 Number of previous abortions after 16 weeks gestation 
 Number of miscarriages  
o Medical problems 
o Previous surgeries  
 Previous cervical surgeries 
 Procedure Data 
o Provider type (i.e. resident, fellow, attending) 
o Provider reported ease of procedure 
o Uterine position 
o Initial cervical dilation 
o Number of osmotic dilators or laminaria placed 
o Time with lidocaine gel before tenaculum 
o Time with paracervical block before tenaculum 
o Total speculum time 
o Complications 
 Procedure VAS Data 
o Anticipated 
o Baseline 
o Speculum insertion 
o Paracervical block (control group only) 
o Tenaculum placement 
o Laminaria/osmotic dilator insertion 
o Post-procedure  
o Overall pain 
 Acceptability Data 
o Gel leakage acceptability (experimental group only) 
o Likelihood to recommend procedure 
o Comfort with tampons 
o Maximum time willing to wait for pain control 
 
Data Analysis and Monitoring 
Enrollment will be reviewed bi-weekly by the research team. Given that there are 
minimal safety risks involved in this study, we do not plan to convene an 
independent Data Safety Monitoring Board (DSMB). 
 
Data Management and Storage 
Data will be entered into and stored on REDCap.  
 


Methods of Analysis 
Data will be exported from REDCap to SPSS Version 23.0 for analysis.  
 
Perioperative characteristics will be examined among the groups using chi 
square test and fisher’s exact test, where appropriate; mean and median VAS 
pain scores will be analyzed with Student’s t-tests and non-parametric tests, 
respectively; mean and median overall satisfaction with pain control and provider 
reported ease of procedure via VAS scores will be compared using Student’s t-
tests and non-parametric tests, respectively; linear regression will be completed 
in multivariable analysis to identify predictors of pain. 
 
Analysis and Dissemination of Results 
Analysis will occur upon completion of study enrollment. The co-investigators 
plan to prepare at least one manuscript for submission to a peer-reviewed 
journal. In addition, the co-investigators will present the results of the study at 
conferences and meetings where appropriate.  
 
Risks and Benefits 
Participants are not promised any benefits from participating in the study. 
 
Potential risks associated with this study are minimal. The risk to the participants’ 
physical, psychological, economic, or social well-being in this study is not 
anticipated to be any different or greater from women not participating in the 
study.  
 
The risks, side effects, and discomforts of the study, whether the subject receives 
lidocaine gel or lidocaine paracervical block, are expected to be similar and 
include:  
 Side effects with medications 
o Lidocaine - with numbing medicine in a woman's cervix, there is an 
infrequent risk of getting a unusual taste in the woman's mouth, 
ringing in her ears, nausea or light-headedness. Rarely, a person 
can have a seizure from the numbing medicine.  
 Pelvic examination: Subjects may infrequently experience some 
discomfort during the pelvic exams  
 Emotional Discomfort: Some of the questions the subject will be asked in 
this study may make the subject feel uncomfortable or embarrassed. She 
can refuse to answer any question that makes her uncomfortable or 
embarrassed, from any person, at any time. 
 
Cost to the Participant and Compensation for Participation 
Participants will not be compensated for their time of participation in this study. 
There will be no additional cost for participation in the study.