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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
local injection of lidocain to the cervix
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
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
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
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
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