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Paracervical Block for Pain Control With Osmotic Dilator Placement

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ClinicalTrials.gov Identifier: NCT02354092
Recruitment Status : Terminated
First Posted : February 3, 2015
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
Lisa Bayer, 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.

Condition or disease Intervention/treatment Phase
Abortion Late Pain Procedure: Local anesthetic for tenaculum placement Procedure: Sham Procedure: Paracervical Block Procedure: Dilator Placement Behavioral: Post-procedural assessment Drug: Preprocedural pain control Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Paracervical Block for Pain Control During Osmotic Dilator Placement: a Randomized Controlled Trial
Actual Study Start Date : April 2, 2015
Actual Primary Completion Date : August 25, 2015
Actual Study Completion Date : August 25, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham Group

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
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

Procedure: Sham
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

Procedure: Dilator Placement

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.


Behavioral: Post-procedural assessment
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.

Drug: Preprocedural pain control
800 mg Ibuprofen taken before dilator placement

Experimental: Paracervical Block Group

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
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

Procedure: Paracervical Block
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

Procedure: Dilator Placement

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.


Behavioral: Post-procedural assessment
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.

Drug: Preprocedural pain control
800 mg Ibuprofen taken before dilator placement




Primary Outcome Measures :
  1. Pain at time of Osmotic Dilator Placement [ Time Frame: 1 year ]
    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time immediately after Osmotic Dilator Placement


Secondary Outcome Measures :
  1. Pain with Paracervical Block or Sham [ Time Frame: 1 year ]
    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time immediately after last injection for paracervical block OR script for sham injection

  2. Baseline and Reported pain at different timepoints [ Time Frame: 1 year ]
    Distance (mm) from the left of the 100-mm VAS scale of baseline and anticipated pain recorded prior to the procedure. Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of speculum insertion, placement of the PCB or Sham, and tenaculum placement.

  3. Pain with Overall Dilator placement [ Time Frame: 1 year ]
    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded 15 minutes after Osmotic Dilator placement.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354092


Locations
United States, California
Planned Parenthood of the Pacific Southwest: First Avenue Family Planning Michelle Wagner Center
San Diego, California, United States, 92101
UCSD Medical Offices South: Women's Health Services
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Planned Parenthood Federation of America
Investigators
Principal Investigator: Lisa Bayer, MD MPH UCSD Department of Reproductive Medicine
Principal Investigator: Sheila Mody, MD MPH UCSD Department of Reproductive Medicine
Principal Investigator: Kelly Culwell, MD MPH Planned Parenthood of the Pacific Southwest

Publications:

Responsible Party: Lisa Bayer, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02354092     History of Changes
Other Study ID Numbers: 141593
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

Keywords provided by Lisa Bayer, University of California, San Diego:
cervical dilation
pain
paracervical block
osmotic dilators

Additional relevant MeSH terms:
Physiological Effects of Drugs
Lidocaine
Anesthetics, Local
Anesthetics
Ibuprofen
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors