Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion

NCT04254081 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 192033
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Buprenorphine; Adjuvants, Anesthesia; Dilation and Evacuation; Analgesics

Keywords

Abortion; Osmotic dilators; Cervical preparation

Outcome Measures

Primary Outcomes (1)

• Pain Score at the Time of Osmotic Dilator Insertion

  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 Outcomes (4)

• Pain Score 2 Hours After Osmotic Dilator Insertion

  2 hours after osmotic dilator insertion

• Pain Score 1 Hour After Osmotic Dilator Insertion

  1 hour after osmotic dilator insertion

• Pain Score 6 Hours After Osmotic Dilator Insertion

  6 hours after osmotic dilator insertion

• Overall Satisfaction Scores

  Morning of D&E procedure: after check-in, before D&E

Study Arms (2)

Buprenorphine 0.15mg + 1% lidocaine paracervical block

EXPERIMENTAL

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

1% lidocaine paracervical block

PLACEBO COMPARATOR

Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate

Drug: Lidocaine 1% Injectable Solution

Interventions

Buprenorphine 0.15 MG DRUG

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.

Buprenorphine 0.15mg + 1% lidocaine paracervical block

Lidocaine 1% Injectable Solution DRUG

20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.

1% lidocaine paracervical block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of California San Diego Health

San Diego, California, 92093, United States

Location

Related Publications (7)

• Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA. Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27.

  PMID: 30500336 BACKGROUND

• Soon R, Tschann M, Salcedo J, Stevens K, Ahn HJ, Kaneshiro B. Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):387-392. doi: 10.1097/AOG.0000000000002149.

  PMID: 28697113 BACKGROUND

• Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.

  PMID: 25139724 BACKGROUND

• Creinin MD, Schimmoeller NR, Matulich MC, Hou MY, Melo J, Chen MJ. Gabapentin for pain management after osmotic dilator insertion and prior to dilation and evacuation: A randomized controlled trial. Contraception. 2020 Mar;101(3):167-173. doi: 10.1016/j.contraception.2019.12.001. Epub 2020 Jan 10.

  PMID: 31927028 BACKGROUND

• Kosel J, Bobik P, Tomczyk M. Buprenorphine--the unique opioid adjuvant in regional anesthesia. Expert Rev Clin Pharmacol. 2016;9(3):375-83. doi: 10.1586/17512433.2016.1141047. Epub 2016 Jan 28.

  PMID: 26758991 BACKGROUND

• Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.

  PMID: 24534592 BACKGROUND

• Swain A, Nag DS, Sahu S, Samaddar DP. Adjuvants to local anesthetics: Current understanding and future trends. World J Clin Cases. 2017 Aug 16;5(8):307-323. doi: 10.12998/wjcc.v5.i8.307.

  PMID: 28868303 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Dilatation, Pathologic

Interventions

Buprenorphine; Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: UCSD Family Planning Research
• Organization: University of California, San Diego

familyplanningresearch@health.ucsd.edu

(858) 329-4464

Study Officials

• Nicole Economou, MD

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

• Sheila K Mody, MD, MPH

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: May 28, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Locations

US (1)