Intrauterine Lidocaine for Laminaria

Study Overview
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Brief Summary
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This is a study to investigate whether instilling a small amount of liquid lidocaine into the uterus will decrease pain felt by women during laminaria insertions done for cervical dilation prior to second trimester abortion. The investigators hypothesize that women who receive intrauterine lidocaine in addition to a paracervical block will experience less pain than women who receive only a paracervical block.

Official Title
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Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)

Conditions
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Abortion, Induced, Pain Management

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Can sign informed consent Healthy pregnant females Weight over 45kg Seeking abortion by dilation and evacuation in the second trimester of pregnancy Gestational age 14-24 weeks confirmed by clinic ultrasound Exclusion Criteria: Known allergy or previous reaction to lidocaine, bupivicaine or other anesthetic agent Known allergy or previous reaction to ibuprofen or other NSAID

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrauterine Lidocaine<br>The experimental arm will receive 100mg lidocaine (5mL of 2% concentration) instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion. | Drug: Lidocaine<br>* 100mg of liquid lidocaine, single dose, instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.<br>|
| Placebo Comparator: Intrauterine Saline<br>Placebo arm will receive 5mL of normal saline instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion. | Drug: Normal Saline<br>* 5mL of normal saline, instilled into the uterus via a flexible trans-cervical catheter immediately prior to laminaria insertion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale |  | Immediately following laminaria insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale |  | 24-48 hours after laminaria insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abortion, Induced, Pain management, Cervical preparation, Dilation and Evacuation, Laminaria