Intracervical Block During Laminaria Insertion

June 22, 2024 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study
a 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine).
Procedure: Intracervical block
local injection of lidocain to the cervix
Sham Comparator: Control
a 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline
Procedure: Intracervical block
local injection of lidocain to the cervix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level using 0-100 Visual Analog Scale (100=worst pain)
Time Frame: During the procedure
Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale
During the procedure
Rate of patient reporting severe pain (VAS 75-100) during laminaria insertion
Time Frame: During the procedure
Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of complications
Time Frame: During and immediately after the procedure
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
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
Time Frame: Immediately after the procedure
Patients will be asked to state whether they find the procedure they undergone acceptable
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Matan Mor, MD, Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 16, 2024

First Submitted That Met QC Criteria

June 22, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 22, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASF-0020-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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