Paracervical Versus Intracervical Lidocaine

Study Overview
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Brief Summary
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The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.

Official Title
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Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial

Conditions
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Abortion, Induced, Pain

Intervention / Treatment
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* Procedure: Paracervical block
* Procedure: Intracervical
* Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women presenting for elective first trimester abortion Exclusion Criteria: Gestation over 12 weeks by ultrasound Weight less than 98 pounds Known allergy to lidocaine Known nonviable pregnancy

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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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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: Paracervical block<br>* The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.<br>Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate<br>* The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.<br>|
| Experimental: 2<br> | Procedure: Intracervical<br>* The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.<br>Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate<br>* The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS) | VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain | at completion of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Age at Time of Procedure |  | At the time of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Local anesthesia, Paracervical, Intracervical, Abortion, Local anesthesia for elective first trimester abortion