Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion (ABC for D&E)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254081
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Nicole Economou, MD, University of California, San Diego

Brief Summary:

Cervical preparation with osmotic dilators is commonly used prior to dilation and evacuation (D&E) procedures to decrease the risk of complications. Women have described the pain of osmotic dilator insertion as moderate to severe yet there have been few studies aimed at addressing pain during and after osmotic dilator insertion. In addition to the discomfort during insertion, pain after osmotic dilator insertion peaks at 2 hours post-insertion with use of a lidocaine paracervical block. One randomized trial found that use of a paracervical block with 1% buffered lidocaine decreased pain with osmotic dilator insertion compared to a sham block. There are adjunct treatments to optimize analgesia with local anesthetics at a variety of anatomic locations. Buprenorphine, a partial mu-opioid receptor agonist, has been found to increase the quality of the anesthetic at the time of administration and increase the duration of nerve block analgesia at several anatomic sites, though has never been studied as an adjunct in a paracervical block. This has been used extensively in orthopedic surgery with significant prolongation of the local anesthetic effect by almost threefold in some studies.

Primary Aim: To compare the mean pain score at the time of osmotic dilator insertion among women randomized to a 1% lidocaine and buprenorphine paracervical block compared to a 1% lidocaine paracervical block alone.

Secondary Aim: To compare the mean pain score 2 hours after osmotic dilator insertion among women randomized to a lidocaine and buprenorphine paracervical block compared to a lidocaine paracervical block alone.

The investigators hypothesize that in patients undergoing osmotic dilator insertion in preparation for dilation and evacuation, the addition of buprenorphine 0.15mg to a 1% lidocaine paracervical block will be associated with lower mean pain scores at time of osmotic dilator insertion compared to women who receive a 1% lidocaine paracervical block alone.


Condition or disease Intervention/treatment Phase
Procedural Pain Buprenorphine Adjuvants, Anesthesia Dilation and Evacuation Analgesics Drug: Buprenorphine 0.15 MG Drug: Lidocaine 1% Injectable Solution Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, placebo controlled trial with stratified block randomization based on vaginal parity (vaginally nulliparous versus vaginally multiparous). Vaginal parity may influence pain during osmotic dilator insertion and thus the participants will be evenly distributed between strata.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A clinician who will not be administering the paracervical block will open the designated sealed sequentially numbered opaque randomization envelope containing computer generated randomization code and prepare the designated paracervical block into two 10 mL syringes. The syringes used to prepare the medication will be identical between study groups and the solutions will appear visually identical. A different clinician blinded to the treatment group will perform the standardized procedure for osmotic dilator insertion.
Primary Purpose: Treatment
Official Title: Addition of Buprenorphine to Paracervical Block Prior to Osmotic Dilator Insertion for Dilation and Evacuation: A Randomized Controlled Trial
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buprenorphine 0.15mg + 1% lidocaine paracervical block
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Drug: Buprenorphine 0.15 MG
Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.

Placebo Comparator: 1% lidocaine paracervical block
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Drug: Lidocaine 1% Injectable Solution
20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.




Primary Outcome Measures :
  1. Pain score at the time of osmotic dilator insertion [ Time Frame: Assessed immediately after last dilator inserted ]
    Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale at the time of osmotic dilator insertion


Secondary Outcome Measures :
  1. Pain score 2 hours after osmotic dilator insertion [ Time Frame: 2 hours after osmotic dilator insertion ]
    Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 2 hours after osmotic dilator insertion assessed via text message

  2. Pain score 1 hour after osmotic dilator insertion [ Time Frame: 1 hour after osmotic dilator insertion ]
    Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 1 hour after osmotic dilator insertion assessed via text message

  3. Pain score 6 hours after osmotic dilator insertion [ Time Frame: 6 hours after osmotic dilator insertion ]
    Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 6 hours after osmotic dilator insertion assessed via text message

  4. Amount of pain medication required after dilator insertion [ Time Frame: Collected with each subject contact (1 hour, 2 hours, 6 hours after osmotic dilator insertion and at time of presentation for D&E) ]
    Assessment of overall pain medication use (narcotic and/or ibuprofen) between both group after osmotic dilator placement and before dilation and evacuation procedure. Subject report of how many tablets of medication they have taken. This will be assessed via text message.

  5. Frequency of opioid related side effects [ Time Frame: Collected with each subject contact (immediately after dilator placement, 1 hour, 2 hours, 6 hours after osmotic dilator insertion and at time of presentation for D&E) ]
    Assessment of side effects: nausea, vomiting, dizziness, headache, sweating, feeling sleepy. This will be assessed immediately after dilator insertion and via text message at specified time points after dilator insertion.

  6. Patient satisfaction: Likert scale [ Time Frame: 5 minutes after dilator insertion and on the morning of D&E procedure ]

    To determine patient satisfaction with pain control during and after osmotic dilator insertion. This will be assessed 5 minutes after dilator insertion and on the morning of D&E procedure. Participants will be asked the following questions and rate responses on a Likert scale:

    • How satisfied are you with the amount of pain control that you had during the procedure?
    • Would you recommend the form of pain control you received today to a friend who was going to have this procedure?
    • If you had to have these dilators placed for a procedure in the future, would you choose to have the same pain medication that you received during your procedure?



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age 14 0/7 weeks to 23 6/7 weeks at time of osmotic dilator insertion
  • Require cervical preparation with placement of osmotic dilators
  • At least 18 years of age
  • Fluent in English or Spanish

Exclusion Criteria:

  • Same day dilation and evacuation procedure
  • Request for sedation during osmotic dilator insertion
  • Liver disease
  • Allergy to buprenorphine, lidocaine, or ibuprofen
  • Narcotic or opioid medication use in the preceding 24 hours
  • Use of recreational/illicit medications in the preceding 24 hours
  • Currently incarcerated

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): NCT04254081


Contacts
Layout table for location contacts
Contact: Nicole Economou, MD 323-523-5486 nieconomou@health.ucsd.edu
Contact: Marisa Hildebrand, MPH mchildeb@health.ucsd.edu

Locations
Layout table for location information
United States, California
University of California San Diego Health Recruiting
San Diego, California, United States, 92093
Contact: Nicole Economou, MD    323-523-5486    nieconomou@health.ucsd.edu   
Contact: Marisa Hildebrand, MPH       mchildeb@health.ucsd.edu   
Principal Investigator: Nicole Economou, MD         
Sponsors and Collaborators
University of California, San Diego
Society of Family Planning
Investigators
Layout table for investigator information
Principal Investigator: Nicole Economou, MD UC San Diego Health
Publications:

Layout table for additonal information
Responsible Party: Nicole Economou, MD, Family Planning Fellow, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04254081    
Other Study ID Numbers: 192033
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nicole Economou, MD, University of California, San Diego:
Abortion
Osmotic dilators
Cervical preparation
Additional relevant MeSH terms:
Layout table for MeSH terms
Dilatation, Pathologic
Pain, Procedural
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Lidocaine
Buprenorphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
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
Analgesics, Opioid
Narcotics
Analgesics
Narcotic Antagonists