Intracervical Block During Laminaria Insertion

Shamir Medical Center (Assaf-Harofeh)

Status: Not yet enrolling

Conditions: Late Abortion; Dilation and Evacuation

Treatments: Procedure: Intracervical block

Study type: Interventional

Funder types: Other

Identifiers

NCT06478316

ASF-0020-24

Details and patient eligibility

About

Whether intracervical block with lidocaine 1% is superior to sham procedure - intracervical injection of saline 0.9% - in terms of pain control.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Voluntary termination of pregnancy approved by a committee or missed abortion
• 18.0 to 22.5 gestational week (The gestational age in the case of a missed abortion is determined by the BPD - Biparietal Diameter, which is the determining measure for the ability to perform D&E.)
• Singleton pregnancy

Exclusion criteria

• Multiple pregnancy
• Women undergoing the procedure urgently due to cervical insufficiency, inevitable abortion, premature rupture of membranes, or suspected chorioamnionitis
• Allergy to lidocaine
• Women who do not speak Hebrew or English
• Women who have a guardian for any reason
• Women with a history of cesarean section
• Women with abnormal placental implantation, such as placenta previa or suspected placenta accreta
• Women with a psychiatric illness
• Women with a history of alcoholism or drug abuse
• Women who required a "two-stage" laminaria insertion will not be included in the analysis. In cases where the cervix does not allow the insertion of the required number of laminaria, the process is carried out in two stages: in the first stage, the maximum possible number is inserted, the woman is hospitalized, and after a few hours when some initial dilation of the cervix has occurred, the laminaria are removed and new ones are inserted according to the required number

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Study

Experimental group

Description:

a 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine).

Treatment:

Procedure: Intracervical block

Control

Sham Comparator group

Description:

a 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline

Treatment:

Procedure: Intracervical block