Phase 4
Completed N=332
Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Source: ClinicalTrials.gov NCT01466491 ↗Enrolled (actual)
332
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Patient Perception of Pain — 60; 68; 56; 63 mm
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Perception of Pain |
60; 68; 56; 63 | — |
| SECONDARY Pain Scores Throughout Procedure at Various Time Points |
7.65; 4.84; 4.2; 6; 29.35; 27.31 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01466491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.