Clinical trial NCT02354092
Conditions: Abortion Late Pain
Keywords: cervical dilation pain paracervical block osmotic dilators
Sponsor: University of California, San Diego
Start date: 2015-04-02; Completion date: 2015-08-25
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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 arm 2: 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
Interventions: intervention 1: Local anesthetic for tenaculum placement intervention 2: Sham intervention 3: Paracervical Block intervention 4: Dilator Placement intervention 5: Post-procedural assessment intervention 6: Preprocedural pain control
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: 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 intervention 4: 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. intervention 5: 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. intervention 6: 800 mg Ibuprofen taken before dilator placement

Protocol documents: