Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o

Abortion in First Trimester Clinical Trial

Official title:

Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636451
• Other study ID #: 180999.o
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2018
• Est. completion date: September 27, 2022

Study information

• Verified date: March 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are conducting a study on pain control for dilation and curettage (D&C). Participants are eligible to enroll if they are a planning to have a D&C in a participating clinic. The investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix. Both potential methods use the same dose of medication, though researchers would like to know which one works better. To be in this study, participants must be over the age of 18 with an early pregnancy loss or undesired pregnancy measuring less than 12 weeks gestation undergoing D&C while awake in clinic.

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.

Other known NCT identifiers

• NCT03736681

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 27, 2022
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women over the age of 18 presenting to UC San Diego and UC Los Angeles

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:

1. Women with a diagnosis of inevitable or incomplete abortion

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

Related Conditions & MeSH terms

• Abortion Early
• Abortion in First Trimester
• Abortion, Missed
• Abortion, Spontaneous
• Pain Uterus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Villa La Jolla Clinic	La Jolla	California
United States	UCSD Medical Offices South	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Society of Family Planning, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain With 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	Pain With 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.
Secondary	Pain 10 Minutes Post Procedure	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.
Secondary	Overall Pain	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.

External Links

•   Guttmacher Institute: Facts on Induced Abortion Worldwide