Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478316
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-16
Brief Title:
Intracervical Block During Laminaria Insertion
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Pain Control With Intracervical Block During Laminaria Insertion for Late Abortions a Double Blind Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Whether intracervical block with lidocaine 1 is superior to sham procedure - intracervical injection of saline 09 - 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 09 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 09 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 oclock positions after prior aspiration with a 23-gauge needle about 2 ml per point
Laminaria type to be inserted - small diameter 3 mm length 65 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 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 09 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 09 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 oclock positions after prior aspiration with a 23-gauge needle about 2 ml per point
Laminaria type to be inserted - small diameter 3 mm length 65 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None