Paracervical Block for Pain Control With Osmotic Dilator Placement

University of California San Diego

Status: Terminated

Conditions: Abortion Late; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02354092

141593

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Sham Group

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham

Behavioral: Post-procedural assessment

Procedure: Local anesthetic for tenaculum placement

Drug: Preprocedural pain control

Procedure: Dilator Placement

Paracervical Block Group

Experimental group

Description:

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

Treatment:

Behavioral: Post-procedural assessment

Procedure: Paracervical Block

Procedure: Local anesthetic for tenaculum placement

Drug: Preprocedural pain control

Procedure: Dilator Placement