N/A
N=41
Paracervical Block for Pain Associated With Laminaria Insertion
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02454296 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Pain After Placement of Laminaria (100 mm Visual Analog Scale) — 13; 54 units on a scale (100 mm VAS) — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Paracervical Block with lidocaine (Drug); Sham paracervical block (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Hawaii
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain After Placement of Laminaria (100 mm Visual Analog Scale) |
13; 54 | 0.01 sig |
| SECONDARY Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) |
95; 70 | 0.05 |
| SECONDARY Paracervical or Sham Block Pain |
14; 27 | 0.34 |
Summary
To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.
Eligibility Criteria
Inclusion Criteria
- Pregnant women between the ages of 18-49 years
- Desiring surgical termination of pregnancy or surgical management of a fetal demise
- Treatment plan involves cervical preparation with laminaria
- Participant able to provide informed consent in English and willing to participate in the study
Exclusion Criteria
- Unable to read/speak/understand English
- Contraindications to receiving lidocaine
Data sourced from ClinicalTrials.gov (NCT02454296). 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.