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

NCT03636451 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 180999.o
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Dilation & curettage; Paracervical block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain With Uterine Aspiration

  Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.

• Pain 10 Minutes Post Procedure

  Once 10 minutes after the procedure on the day of recruitment, approximately one minute.

• Overall Pain

  Once 10 minutes after the procedure on the day of recruitment, approximately one minute.

Study Arms (2)

40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block

EXPERIMENTAL

40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation

Drug: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block

20cc 1% lidocaine with 2 units of vasopressin paracervical block

ACTIVE COMPARATOR

20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation

Drug: 20cc 1% lidocaine with 2 units of vasopressin paracervical block

Interventions

40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block DRUG

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.

Also known as: 40cc

40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block

20cc 1% lidocaine with 2 units of vasopressin paracervical block DRUG

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.

Also known as: 20cc

20cc 1% lidocaine with 2 units of vasopressin paracervical block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Villa La Jolla Clinic

La Jolla, California, 92037, United States

Location

UCSD Medical Offices South

San Diego, California, 92103, United States

Location

Related Publications (17)

• 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.

  PMID: 19370649 BACKGROUND

• 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.

  PMID: 20399943 BACKGROUND

• 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.

  PMID: 19407522 BACKGROUND

• 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.

  PMID: 2710563 BACKGROUND

• 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.

  PMID: 9544719 BACKGROUND

• 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.

  PMID: 2686702 BACKGROUND

• 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.

  PMID: 15773879 BACKGROUND

• 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.

  PMID: 19341852 BACKGROUND

• 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.

  PMID: 980095 BACKGROUND

• 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.

  PMID: 22525915 BACKGROUND

• 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.

  PMID: 27235677 BACKGROUND

• 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.

  PMID: 14622683 BACKGROUND

• 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.

  PMID: 11690725 BACKGROUND

• 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.

  PMID: 8604867 BACKGROUND

• 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.

  PMID: 17339617 BACKGROUND

• 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.

  PMID: 18929686 BACKGROUND

• 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.

  PMID: 35852274 DERIVED

Related Links

• Guttmacher Institute: Facts on Induced Abortion Worldwide

MeSH Terms

Conditions

Abortion, Spontaneous; Abortion, Missed; Dilatation, Pathologic

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Limitations of our study include a lack of variation in the clinical setting for which the dilation and aspiration procedures were performed (outpatient clinics at large academic centers) limiting the generalizability of the study to community care settings. The study was powered to evaluate only a 20-mm difference in pain control within each stratum of the cohort. Larger sample sizes in each stratum could potentially detect a more subtle effect on pain control.

Results Point of Contact

• Title: Sheila Mody
• Organization: University of California, San Diego

smody@health.ucsd.edu

8583294464

Study Officials

• Sheila K Mody, MD MPH

  UCSD Department of Ob/Gyn and Reproductive Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study coordinator, who will be blinded to the intervention, will pick the designated sealed, opaque envelope containing the type of paracervical block and hand it to the physician performing the procedure. The physician will then open the envelope and prepare the designated paracervical block, as it is standard practice for physicians to prepare their own paracervical blocks prior to performing any D\&C in-clinic. The paracervical block will contain 2U Vasopressin, 2cc of 8.4% sodium bicarbonate, and either 1% lidocaine or 0.5% lidocaine, depending on the study group. The physician will bring the paracervical block into the clinic room where the procedure will be performed on a covered tray. The physician will perform the standardized procedure for the D\&C, and the study coordinator will assess pain control during the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a double center, randomized, 2 arm (1:1), single blinded clinical trial comparing pain control at the time of cervical dilation with two different paracervical blocks in women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: October 29, 2018
• Primary Completion: December 14, 2020
• Study Completion: September 27, 2022
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)