Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
NCT ID: NCT03636451
Last Updated: 2023-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2018-10-29
2022-09-27
Brief Summary
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Detailed Description
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An inclusion criterion for this study is that patients must specifically be referred to family planning clinics at UCSD and UCLA for an in-clinic D\&C. Therefore, the D\&C is a required procedure for both study groups. The only difference in care between the study groups will be which paracervical block they receive.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
20cc 1% lidocaine with 2 units of vasopressin paracervical block
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
Interventions
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40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
20cc 1% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Undesired pregnancy or missed abortion \< 11 weeks 6 days gestation
3. Must speak English or Spanish
4. Desire surgical termination of pregnancy or management of miscarriage in clinic
Exclusion Criteria
2. Desire for general anesthesia or IV sedation
3. Chronic pain conditions
4. Any medical comorbidities that are a contraindication to performing the procedure in the clinic setting
5. Allergy to or refusal of ketorolac, oral Versed, or a paracervical block
6. If they have taken any pain medications the day of presentation to clinic
7. If they have taken Misoprostol the day of presentation to clinic
18 Years
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
University of California, Los Angeles
OTHER
University of California, San Diego
OTHER
Responsible Party
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Sheila Mody
Principal Investigator
Principal Investigators
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Sheila K Mody, MD MPH
Role: PRINCIPAL_INVESTIGATOR
UCSD Department of Ob/Gyn and Reproductive Sciences
Locations
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Villa La Jolla Clinic
La Jolla, California, United States
UCSD Medical Offices South
San Diego, California, United States
Countries
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References
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Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.
Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.
Meckstroth KR, Mishra K. Analgesia/pain management in first trimester surgical abortion. Clin Obstet Gynecol. 2009 Jun;52(2):160-70. doi: 10.1097/GRF.0b013e3181a2b0e8.
Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-350. doi: 10.1016/0304-3959(89)90094-8.
Rawling MJ, Wiebe ER. Pain control in abortion clinics. Int J Gynaecol Obstet. 1998 Mar;60(3):293-5. doi: 10.1016/s0020-7292(97)00254-3. No abstract available.
Stubblefield PG. Control of pain for women undergoing abortion. Suppl Int J Gynecol Obstet. 1989;3:131-40. doi: 10.1016/0020-7292(89)90113-6.
Pud D, Amit A. Anxiety as a predictor of pain magnitude following termination of first-trimester pregnancy. Pain Med. 2005 Mar-Apr;6(2):143-8. doi: 10.1111/j.1526-4637.2005.05030.x.
O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11.
Grimes DA, Cates W Jr. Deaths from paracervical anesthesia used for first-trimester abortion, 1972-1975. N Engl J Med. 1976 Dec 16;295(25):1397-9. doi: 10.1056/NEJM197612162952503.
Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.
Renner RM, Edelman AB, Nichols MD, Jensen JT, Lim JY, Bednarek PH. Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. Contraception. 2016 Nov;94(5):461-466. doi: 10.1016/j.contraception.2016.05.005. Epub 2016 May 25.
Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.
Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Crouthamel B, Economou N, Averbach S, Rible R, Kully G, Meckstroth K, Mody SK. Effect of Paracervical Block Volume on Pain Control for Dilation and Aspiration: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):234-242. doi: 10.1097/AOG.0000000000004862. Epub 2022 Jul 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Guttmacher Institute: Facts on Induced Abortion Worldwide
Other Identifiers
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180999.o
Identifier Type: -
Identifier Source: org_study_id
NCT03736681
Identifier Type: -
Identifier Source: nct_alias
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