Clinical trial NCT06478316: Intracervical Block During Laminaria Insertion
Official title: Pain Control With Intracervical Block, During Laminaria Insertion for Late Abortions, a Double Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Late Abortion
Dilation and Evacuation
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-06-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Pain level using 0-100 Visual Analog Scale (100=worst pain)
timeFrame: During the procedure
measure: Rate of patient reporting severe pain (VAS 75-100) during laminaria insertion
timeFrame: During the procedure
Secondary outcomes:
measure: The rate of complications
timeFrame: During and immediately after the procedure
measure: Acceptability of the procedure measured as the rate of patients who will state that they found the procedure acceptable
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Matan Mor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.