Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion
Condition: Procedural Pain; Buprenorphine; Adjuvants, Anesthesia; Dilation and Evacuation; Analgesics
MeSH terms: Dilatation, Pathologic; Pain, Procedural
Intervention: Buprenorphine 0.15 MG; Lidocaine 1% Injectable Solution
Intervention description: 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.; 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
Intervention MeSH terms: Lidocaine; Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 57.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abortion; Osmotic dilators; Cervical preparation

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.
    

Eligibility 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