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Whether intracervical block with lidocaine 1% is superior to sham procedure - intracervical injection of saline 0.9% - in terms of pain control.
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
All women will be offered to take 400 mg of ibuprofen about half an hour before the procedure.
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).
Number of participants in the study - 70.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | a 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine). |
|
| Control | Sham Comparator | a 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracervical block | Procedure | local injection of lidocain to the cervix |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the procedure |
| 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 | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During and immediately after the procedure |
| Acceptability of the procedure measured as the rate of patients who will state that they found the procedure acceptable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matan Mor, MD | Contact | 00972506462862 | MatanMorMiz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Matan Mor, MD | Assaf-Harofeh Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18061709 | Result | 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. | |
| 6708260 | Result | Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11. |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patients will be asked to state whether they find the procedure they undergone acceptable |
| Immediately after the procedure |
| 22682721 | Result | 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. |
| 17963864 | Result | 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. |
| 25139724 | Result | 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. |
| 27684047 | Result | 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. |
| 25891258 | Result | 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. |
| 31281014 | Result | 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. |
| 31927028 | Result | 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. |