- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636451
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Dilation and Curettage (D&C) is often performed in the first trimester for surgical abortion and management of miscarriage and can be painful for patients before and after the procedure. Most procedures are performed while the patient is awake or with minimal sedation in the clinic setting, and a key component of pain control is the paracervical block, or injecting lidocaine into the tissue around the cervix. A paracervical block with 20cc of 1% buffered lidocaine has been proven to provide superior pain control than a sham paracervical block. However, many providers often use similar doses of lidocaine in a higher volume to improve pain control. At University of California, San Diego (UCSD) and University of California, Los Angeles (UCLA), some providers routinely use a 20cc of 1% buffered lidocaine block and some routinely use a 40cc of 0.5% buffered lidocaine block. This practice has not been studied in a randomized controlled trial. The purpose of this study is to compare pain control during D&C with a 20cc 1% buffered lidocaine with vasopressin paracervical block compared to a 40cc 0.5% buffered lidocaine with vasopressin paracervical block.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Villa La Jolla Clinic
-
San Diego, California, United States, 92103
- UCSD Medical Offices South
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women over the age of 18 presenting to UC San Diego and UC Los Angeles
- Undesired pregnancy or missed abortion < 11 weeks 6 days gestation
- Must speak English or Spanish
- Desire surgical termination of pregnancy or management of miscarriage in clinic
Exclusion Criteria:
- Women with a diagnosis of inevitable or incomplete abortion
- Desire for general anesthesia or IV sedation
- Chronic pain conditions
- Any medical comorbidities that are a contraindication to performing the procedure in the clinic setting
- Allergy to or refusal of ketorolac, oral Versed, or a paracervical block
- If they have taken any pain medications the day of presentation to clinic
- If they have taken Misoprostol the day of presentation to clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
Other Names:
|
Active Comparator: 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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain With Cervical Dilation
Time Frame: Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.
|
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded at time of cervical dilation.
Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
|
Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain With Uterine Aspiration
Time Frame: Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.
|
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded immediately after uterine aspiration.
Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
|
Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.
|
Pain 10 Minutes Post Procedure
Time Frame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
|
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded 10 minutes after the completion of the procedure.
Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
|
Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
|
Overall Pain
Time Frame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
|
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded after the procedure reflecting the overall pain felt during the procedure.
Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
|
Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sheila K Mody, MD MPH, UCSD Department of Ob/Gyn and Reproductive Sciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Pregnancy Complications
- Abortion, Spontaneous
- Dilatation, Pathologic
- Abortion, Missed
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Natriuretic Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Hemostatics
- Coagulants
- Vasoconstrictor Agents
- Antidiuretic Agents
- Lidocaine
- Vasopressins
- Arginine Vasopressin
Other Study ID Numbers
- 180999.o
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abortion in First Trimester
-
Central Hospital, Nancy, FranceCompletedAbortion in First Trimester | Abortion, Second Trimester
-
University of California, San DiegoRecruiting
-
Stanford UniversityGynuity Health ProjectsTerminated
-
KK Women's and Children's HospitalRecruitingAbortion in First TrimesterSingapore
-
Washington University School of MedicineCompletedAbortion in First TrimesterUnited States
-
University of Cape TownKarolinska Institutet; University of California, San Francisco; Grand Challenges...Recruiting
-
Planned Parenthood of Greater New YorkCompletedAbortion in First TrimesterUnited States
-
University of New MexicoCompletedAbortion in First TrimesterUnited States
-
Dr. Marie Eve Sophie Bussiere-CoteSuspendedAbortion in First TrimesterCanada
-
Columbia UniversitySociety of Family PlanningCompleted
Clinical Trials on 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block
-
University of HawaiiCompleted
-
University of California, San DiegoCompleted
-
Damascus UniversityCompletedLocal AnesthesiaSyrian Arab Republic
-
Jessa HospitalCompletedAnesthesia, Local | SurgeryBelgium
-
Stanford UniversityCompletedPain Management, Cervical PreparationUnited States
-
Mahidol UniversityCompletedAbnormal Uterine Bleeding | Endometrial BiopsyThailand
-
Oregon Health and Science UniversityPlanned Parenthood Federation of AmericaCompleted
-
Stanford UniversityCompletedPregnancy, UnwantedUnited States
-
Chiang Mai UniversityCompleted
-
Kasr El Aini HospitalCompletedQuality of Ocular Akinesia (Onset and Duration)Egypt