Paracervical Block for Pain Control With Osmotic Dilator Placement

Not Applicable

Terminated

Conditions: Abortion Late
Pain

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

Registration Number: NCT02354092

Lead Sponsor: University of California, San Diego

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 14

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Group	Sham	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
Sham Group	Local anesthetic for tenaculum placement	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
Sham Group	Dilator Placement	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
Sham Group	Preprocedural pain control	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
Paracervical Block Group	Local anesthetic for tenaculum placement	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
Paracervical Block Group	Preprocedural pain control	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
Sham Group	Post-procedural assessment	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
Paracervical Block Group	Post-procedural assessment	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
Paracervical Block Group	Paracervical Block	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
Paracervical Block Group	Dilator Placement	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

Primary Outcome Measures

Name	Time	Method
Pain at Time of Osmotic Dilator Placement	Within 5 minutes of PCB or sham procedure	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.

Secondary Outcome Measures

Name	Time	Method
Reported Pain at Baseline	Baseline, just prior to PCB or sham procedure	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.
Pain With Paracervical Block or Sham	Within 5 minutes after baseline	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.
Pain With Overall Dilator Placement	15 minutes after 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.

Trial Locations

Locations (2): Planned Parenthood of the Pacific Southwest: First Avenue Family Planning Michelle Wagner Center
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San Diego, California, United States
UCSD Medical Offices South: Women's Health Services
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San Diego, California, United States