Phase 4
N=50
Paracervical Block Versus No Paracervical Block During IUD Insertion
Analgesia · IUD Insertion
Bottom Line
View on ClinicalTrials.gov: NCT02904915 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Pain Score as Assessed by a Visual Analogue Scale (VAS) — 2.4; 2.1 units on a scale — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine (Drug); No analgesia (Other); Intrauterine device (IUD) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score as Assessed by a Visual Analogue Scale (VAS) |
2.4; 2.1 | 0.59 |
| PRIMARY Pain Score as Assessed by a Visual Analogue Scale |
2.6; 3.6 | 0.23 |
| PRIMARY Pain Score as Assessed by a Visual Analogue Scale |
2.6; 3.6 | 0.23 |
Summary
The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.
Eligibility Criteria
Inclusion Criteria
- Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.
Exclusion Criteria
- Women with current pelvic inflammatory disease (PID)
- Women who are not good candidates for an IUD
- Patients who have a Lidocaine allergy
Data sourced from ClinicalTrials.gov (NCT02904915). 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.