Paracervical Block for Pain Associated With Laminaria Insertion

Study Overview
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Brief Summary
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To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Detailed Description
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Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Official Title
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Paracervical Block for Pain Associated With Laminaria Insertion

Conditions
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Pain

Intervention / Treatment
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* Drug: Paracervical Block with lidocaine
* Drug: Sham paracervical block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women between the ages of 18-49 years Desiring surgical termination of pregnancy or surgical management of a fetal demise Treatment plan involves cervical preparation with laminaria Participant able to provide informed consent in English and willing to participate in the study Exclusion Criteria: Unable to read/speak/understand English Contraindications to receiving lidocaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracervical Block with lidocaine<br>A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. | Drug: Paracervical Block with lidocaine<br>* Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion<br>* Other names: Paracervical block;|
| Sham Comparator: Sham paracervical block<br>A sham block will be done prior to the placement of laminaria using a capped needle | Drug: Sham paracervical block<br>* A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes<br>* Other names: Sham block; placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain After Placement of Laminaria (100 mm Visual Analog Scale) | We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. | Measured within 10 seconds after placement of laminaria | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) | Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied | 15 minutes post-operatively | 
| Paracervical or Sham Block Pain | Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. | Within 10 seconds after receiving paracervical or sham block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laminaria