Legal Abortion With Complication, Pain
Conditions
Keywords
Paracervical Block, pain control, abortion
Brief summary
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
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.
Interventions
PROCEDUREParacervical Block
Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.
PROCEDURESham Paracervical Block
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.
Sponsors
Planned Parenthood Federation of America
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reported with cervical dilation | 1 Year | Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anticipated and reported pain at various time points | 1 Year | 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. |
| Anxiety reported with the pain expected during the procedure and the procedure itself. | 1 Year | Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of anxiety) recorded prior to procedure. |
| Satisfaction reported with pain control and overall procedure | 1 Year | Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of satisfaction) recorded post procedure. |
| Need for additional intraoperative and/or postoperative pain medication | 1 Year | 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. |
Countries
United States
Outcome results
None listed