Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

Study Overview
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Brief Summary
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The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that varying paracervical block techniques might have on that pain. These different techniques involve wait time following the injection as well as the number of sites injected.

Detailed Description
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The investigators plan to conduct a single-blinded randomized trial of 350 women undergoing elective first-trimester surgical abortion. Subjects will be randomized to two different paracervical block techniques, but both the medications and the amount of medications will remain the same. Subjects will not know to which group they have been randomized as this knowledge may affect how much pain is felt. Primary Outcome: Patient reported pain with cervical dilation during first trimester surgical abortion. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. The 100-mm VAS scale is a well established and validated study instrument. Secondary Outcomes: Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms Pain (VAS scale): anticipated baseline with speculum insertion with placement of the PCB with aspiration 30 min postoperatively intrapersonal pain changes (calculated in analysis) anxiety [baseline] (VAS scale; anchors 0 = none, 100mm = worst imaginable): of pain of surgery satisfaction (VAS scale; anchors 0 = not, 100mm = very satisfied): with pain control overall abortion experience adverse events need for additional intraoperative and/or postoperative pain medication participants' belief if they were in the intervention or control group

Official Title
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Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

Conditions
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Pain

Intervention / Treatment
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* Drug: Paracervical block technique with lidocaine


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 generally healthy English or Spanish speaking able or willing to sign an informed consent and agree to terms of the study Exclusion Criteria: gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this gestational age at the study sites) incomplete abortion failed medical abortion required or requested IV sedation (prior to randomization) patient who declines Ibuprofen, Lorazepam or PCB medical contraindication or allergy to any of the study medications chronic use of narcotic pain medication or heroin significant physical or mental health condition adnexal mass or tenderness on pelvic exam consistent with inflammatory disease 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: 99 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 4-site injection<br>The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1). | Drug: Paracervical block technique with lidocaine<br>* The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.<br>|
| Active Comparator: 2-site Injection<br>The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1). | Drug: Paracervical block technique with lidocaine<br>* The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.<br>|
| Placebo Comparator: 4-Site PCB followed by 3-minute wait<br>Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation | Drug: Paracervical block technique with lidocaine<br>* The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.<br>|
| Active Comparator: 4-site PCB followed by no wait<br>Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0). | Drug: Paracervical block technique with lidocaine<br>* The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Perception of Pain | To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. | after completion of cervical dilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores Throughout Procedure at Various Time Points | Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure: prior to medication (baseline) after speculum insertion with placement of PCB with cervical dilation with aspiration 30 minutes post-operatively | up to several hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain during first-trimester surgical abortion