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

192033

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.

2020-05-28

2021-05-04

2021-05-04

Completed

Early phase I

57

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 57, 'type': 'ACTUAL'}}

2023-08-01