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NCT Number: NCT06478316

Intracervical Block During Laminaria Insertion

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracervical block

Procedure

local injection of lidocain to the cervix

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Matan Mor, MD

CONTACT

[email protected]

00972506462862

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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