Paracervical Block for Pain Control in First Trimester Abortion

Study Overview
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Brief Summary
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Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.

Detailed Description
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The investigators expect to have 120 women complete this study, between study sites at OHSU's Center for Women's Health and Planned Parenthood Columbia Willamette in Portland, OR. Every participant will still receive the standard oral medication for pain (ibuprofen) and anxiety (lorazepam). Eligible subjects will be at least 18 years of age, less than 11 weeks pregnant and have already decided to have a surgical abortion. The primary outcome evaluated will be pain reported at time of cervical dilation. The investigators will assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step and pain and satisfaction 30 minutes postoperatively.

Official Title
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An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion

Conditions
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Legal Abortion With Complication, Pain

Intervention / Treatment
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* Procedure: Paracervical Block
* Procedure: Sham Paracervical Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or older Voluntarily requesting pregnancy termination Ultrasound confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age Good general health English or Spanish speaking Be able and willing to sign an informed consent and agree to terms of the study Exclusion Criteria: Gestational ages over 11 0/7 weeks, due to routine misoprostol use at our institutions Incomplete abortion Required or requested narcotics or IV sedation (prior to randomization) Patients who refuse Ibuprofen and paracervical blocks Contraindications or allergies to lidocaine, ibuprofen or ativan Significant physical or mental health condition Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease Patients with known hepatic disease Women, who in the opinion of the investigator are not suitable for the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: No Paracervical Block for Pain Control<br>Subject will not receive a paracervical block during the procedure | Procedure: Sham Paracervical Block<br>* In the non-intervention group, the surgeon performs a sham PCB during which 2 mL buffered lidocaine solution are injected at the tenaculum site, after which a capped needle gently simulates the standard PCB procedure.<br>|
| Active Comparator: Paracervical Block for Pain Control<br>Subject will receive a paracervical block during the procedure. | Procedure: Paracervical Block<br>* Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reported with cervical dilation | Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated and reported pain at various time points | Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of anticipated pain) recorded prior to the procedure. Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of positioning for procedure, speculum insertion, placement of the PCB, aspiration and 30 min postoperatively. | 1 Year | 
| Anxiety reported with the pain expected during the procedure and the procedure itself. | Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of anxiety) recorded prior to procedure. | 1 Year | 
| Satisfaction reported with pain control and overall procedure | Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of satisfaction) recorded post procedure. | 1 Year | 
| Need for additional intraoperative and/or postoperative pain medication | Subjects may request additional pain medication once their procedure has begun or in recovery. The need for additional medication, and what medication was subsequently distributed, will be recorded. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracervical Block, pain control, abortion