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

July 28, 2023 updated by: Sheila Mody, University of California, San Diego

Addition of Buprenorphine to Paracervical Block Prior to Osmotic Dilator Insertion for Dilation and Evacuation: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dilation and evacuation (D&E) is the most common method of second trimester abortion in the United States. Cervical preparation prior to the procedure is essential in order to allow passage of operative instruments and pregnancy tissue safely through the cervix and to decrease the risk of complications. In the second trimester, cervical preparation is typically achieved with placement of osmotic dilators prior to the procedure. Women have described the pain of osmotic dilator insertion as moderate to severe yet there have been few studies aimed at addressing pain during osmotic dilator insertion. A lidocaine paracervical block is commonly used for pain control during other gynecologic procedures including procedures involving cervical dilation like dilation and curettage. One randomized controlled trial found that use of a paracervical block with 1% lidocaine decreased pain with osmotic dilator insertion compared to a sham block. Because the dilators slowly expand after insertion, there is continued discomfort for several hours after placement. Research has shown that pain after osmotic dilator insertion peaks at 2 hours post-insertion with use of a lidocaine paracervical block and a local anesthetic is not sufficient to provide lasting pain relief. Systemic medications, such as gabapentin and narcotic analgesics have been studied to treat post-insertional dilator pain, however these treatments have not been shown to be effective.

There are many adjunct treatments to optimize the duration of local analgesia from a peripheral nerve block. Buprenorphine, a partial mu-opioid receptor agonist, is a high potency, lipophilic opioid and has a high binding capacity for the mu-opioid receptor. Because of the high binding capacity, buprenorphine has the longest duration of action of all opioids. When administered perineurally in combination with a local anesthetic, buprenorphine has been found to drastically increase the duration of analgesia at several anatomic sites, including axillary and subclavian brachial plexus blocks and infragluteal sciatic nerve blocks. With the addition of buprenorphine at doses of 0.15 - 0.3mg, there is significant prolongation of the anesthetic sensory blockade up to three times the duration of the local anesthetic alone. The use of perineural buprenorphine is well established for postoperative analgesia. Buprenorphine itself also has local anesthetic properties. Buprenorphine blocks voltage gated sodium channels and inhibits C-fiber action potentials, thereby contributing to an analgesic effect. Buprenorphine not only prolongs the duration of local anesthetic effect but also improves the analgesic properties when administered in a perineural block.

The addition of buprenorphine to a perineural local anesthetic has not been studied in a paracervical block. This study will be the first trial to assess the efficacy of buprenorphine to provide analgesia for a gynecologic procedure. This medication has the additional benefit of providing long lasting pain relief for procedures that cause continued discomfort after the end of the procedure. The investigators hypothesize that the addition of 0.15mg of buprenorphine to a lidocaine paracervical block will improve pain during osmotic dilator insertion and provide continued pain relief several hours after osmotic dilator insertion. If this intervention proves to provide better pain control than a lidocaine paracervical block alone, it would be an intervention for women during a painful clinic procedure.

A total of 114 women undergoing D&E who require cervical preparation with osmotic dilators will be randomized to one of two study groups: (1) paracervical block with 20mL of 1% buffered lidocaine or (2) paracervical block with 20mL of 1% buffered lidocaine plus 0.15mg of buprenorphine. Participants, clinicians performing the procedure, and study personnel administering questionnaires will be blinded to study assignment. Participants will rate their level of pain on an 11-point numeric rating scale (NRS) during the insertion of osmotic dilators and at several time points after insertion. The primary outcome is to compare the median pain score at the time of osmotic dilator insertion in women randomized to a 1% lidocaine and buprenorphine paracervical block compared to a 1% lidocaine paracervical block alone. Secondary outcomes are to compare the median pain score 2 hours after osmotic dilator insertion; to assess overall narcotic and ibuprofen use after osmotic dilator placement and before dilation and evacuation procedure; to assess opioid related side effects; and to determine patient satisfaction with pain control during and after osmotic dilator insertion.

Primary Hypothesis: The addition of buprenorphine 0.15mg to a paracervical block using 1% lidocaine will be associated with a lower median pain score on the NRS at time of osmotic dilator insertion compared to women who receive a lidocaine paracervical block alone.

Secondary Hypothesis: The addition of buprenorphine 0.15mg to a paracervical block using 1% lidocaine will be associated with a lower median pain score on the NRS 2 hours after osmotic dilator insertion compared to women who receive a lidocaine paracervical block alone.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • University of California San Diego Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed immediately after last dilator inserted

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours after osmotic dilator insertion
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
1 hour after osmotic dilator insertion
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
6 hours after osmotic dilator insertion
Overall Satisfaction Scores
Time Frame: Morning of D&E procedure: after check-in, before D&E

To determine patient satisfaction with pain control during and after osmotic dilator insertion. This was assessed on the morning of D&E procedure. Participants following question and rated responses on a Likert scale:

What was your overall satisfaction with the amount of pain control that you had during the procedure?
Morning of D&E procedure: after check-in, before D&E

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Nicole Economou, MD, UC San Diego Health
  • Principal Investigator: Sheila K Mody, MD, MPH, UC San Diego Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Actual)

May 4, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192033

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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