An interventional study of Lidocaine in Pain Control for Intrauterine Device Insertions, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-10.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lidocaine
1% Lidocaine
Median Visual Analogue Score Measuring Pain
We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points: 1. Speculum placement 2. Tenaculum placement 3. Paracervical block administration(if subject is in this arm) 4. IUD insertion 5. Five minutes post procedure
Time frame: 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure
July 2010- February 2011, Northwestern Medical Faculty Foundation
| Milestone | Paracervical Block | No Paracervical Block |
|---|---|---|
| Started | 26 | 24 |
| Completed | 26 | 24 |
| Not completed | 0 | 0 |
We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points: 1. Speculum placement 2. Tenaculum placement 3. Paracervical block administration(if subject is in this arm) 4. IUD insertion 5. Five minutes post procedure
| units on a scale | Paracervical Block | No Paracervical Block |
|---|---|---|
| 1) Speculum Placement | 12 ± 13.1 | 8.5 ± 12.9 |
| 2) Tenaculum Placement | 12 ± 21.8 | 28 ± 16.2 |
| 3) Paracervical Block administration | 40 ± 29.3 | NA (NA to NA) |
| 4) IUD insertion | 24 ± 35.0 | 62 ± 27.5 |
| 5) 5 minutes post procedure | 12 ± 25.7 | 17 ± 18.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paracervical Block | — | 0/26 (0%) | 0/26 (0%) |
| No Paracervical Block | — | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | Paracervical Block | No Paracervical Block | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 26 | 24 | 50 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Paracervical Block | No Paracervical Block | Total |
|---|---|---|---|
| Mean | 31.9 ± 5.9 | 33.2 ± 6.2 | 32.6 ± 6.0 |
| Sex: Female, Male(Participants) | Paracervical Block | No Paracervical Block | Total |
|---|---|---|---|
| Female | 26 | 24 | 50 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Paracervical Block | No Paracervical Block | Total |
|---|---|---|---|
| United States | 26 | 24 | 50 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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