Procedural Pain Clinical Trial
— ABCD&EOfficial title:
Addition of Buprenorphine to Paracervical Block Prior to Osmotic Dilator Insertion for Dilation and Evacuation: A Randomized Controlled Trial
NCT number | NCT04254081 |
Other study ID # | 192033 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 28, 2020 |
Est. completion date | May 4, 2021 |
Verified date | July 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | May 4, 2021 |
Est. primary completion date | May 4, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Diego Health | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Society of Family Planning |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pain Score 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 | |
Secondary | Pain Score 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 | |
Secondary | Pain Score 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 | |
Secondary | Overall Satisfaction Scores | 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 |
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