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Not yet recruitingNCT06478316Updated Jun 27, 2024

Intracervical Block During Laminaria Insertion

An interventional study of Intracervical block in Late Abortion and Dilation and Evacuation, sponsored by Assaf-Harofeh Medical Center. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Whether intracervical block with lidocaine 1% is superior to sham procedure - intracervical injection of saline 0.9% - in terms of pain control.

Read the detailed description
  • Research Design - Double-blind randomized study
  • Study Population - Women who are candidates for late termination of pregnancy by dilation and evacuation and approach for the insertion of laminaria will be recruited for the study.

  • The women will be divided into two groups

    • Research Group - Women who will undergo preparation for the insertion of laminaria by anesthesia with lidocaine spray, followed by an intracervical injection of 1% lidocaine.
    • Control Group - Women who will be anesthetized with lidocaine spray + intracervical injection of an inactive substance (0.9% saline).
    • Randomization will be performed using dedicated computer software according to blocks of 2-6 women.

  • All women will be offered to take 400 mg of ibuprofen about half an hour before the procedure.

    • In the research group - a 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine).
    • In the control group - a 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline.
  • Primary anesthesia will be performed using 10% lidocaine spray in up to 5 sprays.
  • Injection into the cervix will be performed at 3, 6, 9, 12 o'clock positions, after prior aspiration, with a 23-gauge needle, about 2 ml per point.

  • Laminaria type to be inserted - "small" diameter 3 mm, length 6.5 cm (MedGyn: Lombard, IL, USA, and Norscan: Westlake Village, CA, USA).

    • At weeks 18-20, 7-9 laminaria will be inserted.
    • Over 20 weeks - over 10 laminaria will be inserted.
  • Number of participants in the study - 70.
02

Conditions studied

  • Late Abortion
  • Dilation and Evacuation
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In context

Dilatation, Pathologic

120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.

This study's planned enrollment of 70 is below the median of 82 across 84 interventional studies indexed under Dilatation, Pathologic.

Browse Dilatation, Pathologic studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.

Browse Assaf-Harofeh Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntary termination of pregnancy approved by a committee or missed abortion
  • 18.0 to 22.5 gestational week (The gestational age in the case of a missed abortion is determined by the BPD - Biparietal Diameter, which is the determining measure for the ability to perform D\&E.)
  • Singleton pregnancy

Exclusion criteria

Exclusion Criteria:

  • Multiple pregnancy
  • Women undergoing the procedure urgently due to cervical insufficiency, inevitable abortion, premature rupture of membranes, or suspected chorioamnionitis
  • Allergy to lidocaine
  • Women who do not speak Hebrew or English
  • Women who have a guardian for any reason
  • Women with a history of cesarean section
  • Women with abnormal placental implantation, such as placenta previa or suspected placenta accreta
  • Women with a psychiatric illness
  • Women with a history of alcoholism or drug abuse
  • Women who required a "two-stage" laminaria insertion will not be included in the analysis. In cases where the cervix does not allow the insertion of the required number of laminaria, the process is carried out in two stages: in the first stage, the maximum possible number is inserted, the woman is hospitalized, and after a few hours when some initial dilation of the cervix has occurred, the laminaria are removed and new ones are inserted according to the required number
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Study

    a 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine).

    Procedure: Intracervical block

  • Sham comparator
    Control

    a 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline

    Procedure: Intracervical block

Interventions

  • ProcedureIntracervical block

    local injection of lidocain to the cervix

06

What researchers measure

Primary outcomes

  1. Pain level using 0-100 Visual Analog Scale (100=worst pain)

    Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale

    Time frame: During the procedure

  2. Rate of patient reporting severe pain (VAS 75-100) during laminaria insertion

    Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale

    Time frame: During the procedure

Secondary outcomes

  1. The rate of complications

    Complications during laminaria insertion: rupture of the membranes, cervical bleeding, false route; complication during dilation and evacuation - failure to complete the dilation and evacuation procedure

    Time frame: During and immediately after the procedure

  2. Acceptability of the procedure measured as the rate of patients who will state that they found the procedure acceptable

    Patients will be asked to state whether they find the procedure they undergone acceptable

    Time frame: Immediately after the procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Fox MC, Hayes JL; Society of Family Planning. Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation. Contraception. 2007 Dec;76(6):486-95. doi: 10.1016/j.contraception.2007.09.004. Epub 2007 Nov 9. PubMed 18061709 ↗
  • Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11. PubMed 6708260 ↗
  • Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6. PubMed 22682721 ↗
  • Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4. PubMed 17963864 ↗
  • 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. PubMed 25139724 ↗
  • Shaw KA, Lerma K. Update on second-trimester surgical abortion. Curr Opin Obstet Gynecol. 2016 Dec;28(6):510-516. doi: 10.1097/GCO.0000000000000318. PubMed 27684047 ↗
  • Ramesh S, Roston A, Zimmerman L, Patel A, Lichtenberg ES, Chor J. Misoprostol 1 to 3 h preprocedure vs. overnight osmotic dilators prior to early second-trimester surgical abortion. Contraception. 2015 Sep;92(3):234-40. doi: 10.1016/j.contraception.2015.04.005. Epub 2015 Apr 16. PubMed 25891258 ↗
  • Lerma K, Blumenthal PD. Current and potential methods for second trimester abortion. Best Pract Res Clin Obstet Gynaecol. 2020 Feb;63:24-36. doi: 10.1016/j.bpobgyn.2019.05.006. Epub 2019 May 25. PubMed 31281014 ↗
  • 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. PubMed 31927028 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06478316
Lead sponsor
Assaf-Harofeh Medical Center
Responsible party
Sponsor
First posted
Jun 27, 2024
Start date
Jul 2024 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 27, 2024

Study contacts

Matan Mor, MD
Contact
MatanMorMiz@gmail.com
00972506462862
Matan Mor, MD
principal investigator · Assaf-Harofeh Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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