Paracervical Block for Pain Control With Osmotic Dilator Placement

Study Overview
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Brief Summary
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Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.

Detailed Description
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It is estimated that 1.21 million abortions were performed in 2008. Of these, approximately 11% occurred in the second trimester and 1.4% occurred after 21 weeks gestation. In the United States, dilation and evacuation (D&E) is the most common method of terminating a second trimester pregnancy with greater than 98% of second trimester abortions occurring by D&E. Pre-procedure cervical preparation decreases the incidence of complications associated with D&E. Cervical dilators are often used prior to second trimester D&Es to aid in softening and dilating the cervix. Typically, dilator placement occurs the day of the D&E or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available. Many women experience moderate to severe discomfort with osmotic dilator insertion. Providers use various methods to minimize this discomfort including paracervical block (PCB), non-steroidal anti-inflammatory medications (NSAIDs), anxiolytics and narcotics. In particular, PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose. There is, however, no data to support their efficacy in ameliorating the pain of dilator insertion. Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures. The PCB is thought to work primarily by blocking pain conduction via Frankenhauser's plexus. As such, their effect may be most important in relieving the pain associated with cervical dilation. In a recent randomized control trial, PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration. Since osmotic dilator placement primarily involves cervical manipulation and dilation, PCB may provide some pain relief over placebo. The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement. This trial will also provide information about the degree of pain that women experience during osmotic dilator placement; information not previously known.

Official Title
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Paracervical Block for Pain Control During Osmotic Dilator Placement: a Randomized Controlled Trial

Conditions
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Pain, Abortion Late

Intervention / Treatment
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* Procedure: Local anesthetic for tenaculum placement
* Procedure: Sham
* Procedure: Paracervical Block
* Procedure: Dilator Placement
* Behavioral: Post-procedural assessment
* Drug: Preprocedural pain control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: voluntarily seeking surgical pregnancy termination gestational age on day of study 14w0d to 23w6d confirmed by pelvic ultrasound with a viable pregnancy (no fetal demise diagnosed) eligible for second trimester D&E having osmotic dilators placed for cervical preparation the day prior to D&E able and willing to give informed consent and agree to terms of the study able to speak and read English or Spanish Exclusion Criteria: took any prescription or illegal drugs 24 hours prior to the appointment drank alcohol 12 hours prior to the appointment took any over the counter pain medications 12 hours prior to the appointment other than the standard 800mg of Ibuprofen contraindications to osmotic dilators allergic reaction or hypersensitivity to NSAIDs or lidocaine untreated acute cervicitis or pelvic inflammatory disease weight <100 pounds

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Group<br>This non-intervention group will receive the sham paracervical block. This intervention will include Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement Local anesthetic for tenaculum placement Sham Paracervical Block done with capped spinal needle osmotic dilators placed in the usual fashion postprocedural assessment | Procedure: Local anesthetic for tenaculum placement<br>* 2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate<br>Procedure: Sham<br>* Over 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o'clock positions<br>Procedure: Dilator Placement<br>* Osmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference Drugs: Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix. Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter.<br>Behavioral: Post-procedural assessment<br>* 15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was.<br>Drug: Preprocedural pain control<br>* 800 mg Ibuprofen taken before dilator placement<br>|
| Experimental: Paracervical Block Group<br>This intervention group will receive the paracervical block. This intervention will include Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement Local anesthetic for tenaculum placement 18 ml 1% buffered lidocaine Paracervical Block osmotic dilators placed in the usual fashion postprocedural assessment | Procedure: Local anesthetic for tenaculum placement<br>* 2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate<br>Procedure: Paracervical Block<br>* 18 mL of buffered Lidocaine is slowly injected into the vaginal fornices and equally distributed at 4 and 8 o'clock. The injection is continuous from superficial to deep (3cm) to superficial (injecting with insertion and withdrawal) Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate<br>Procedure: Dilator Placement<br>* Osmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference Drugs: Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix. Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter.<br>Behavioral: Post-procedural assessment<br>* 15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was.<br>Drug: Preprocedural pain control<br>* 800 mg Ibuprofen taken before dilator placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Time of Osmotic Dilator Placement | Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Within 5 minutes of PCB or sham procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain With Paracervical Block or Sham | Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after last injection for paracervical block OR script for sham injection. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Within 5 minutes after baseline | 
| Reported Pain at Baseline | Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) of pain recorded at baseline prior to the paracervical block or sham block procedure. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain. | Baseline, just prior to PCB or sham procedure | 
| Pain With Overall Dilator Placement | Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded 15 minutes after osmotic dilator placement. mm=No Pain and 100 mm= worst possible pain. A higher mean score indicates a higher level of pain experienced at this time point. | 15 minutes after dilator placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical dilation, pain, paracervical block, osmotic dilators