NCT06478316

Intracervical Block During Laminaria Insertion

Pain Control With Intracervical Block, During Laminaria Insertion for Late Abortions, a Double Blind Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Late Abortion
• Dilation and Evacuation

Interventions

Type	Name	Description
PROCEDURE	Intracervical block	local injection of lidocain to the cervix

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-06-27
• Last updated: 2024-06-27