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Pain Control With Intracervical Block, During Laminaria Insertion for Late Abortions, a Double Blind Randomized Control Trial
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 * 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.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
Yes
Start Date
July 1, 2024
Primary Completion Date
July 1, 2026
Completion Date
December 1, 2026
Last Updated
June 27, 2024
70
ESTIMATED participants
Intracervical block
PROCEDURE
Lead Sponsor
Assaf-Harofeh Medical Center
Data Source & Attribution
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