Pain Control for Intrauterine Device Insertions
Conditions
Keywords
intrauterine device, local anesthetic
Brief summary
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.
Interventions
DRUGLidocaine
1% Lidocaine
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women age 18 -50 years * A negative urine pregnancy test and clinically unlikely to be pregnant * Seeking an intrauterine device for any indication * Willing and able to sign an informed consent in English
Exclusion criteria
* History of a prior IUD successful insertion * Previous failed insertion of an IUD * Known copper allergy * Known levonorgestrel allergy * Known lidocaine allergy * Current cervicitis * Pelvic Inflammatory Disease (PID) within 3 months * Pregnancy within six weeks prior to IUD insertion * Uterine anomaly or distortion of the uterine cavity * Use of any other pain medication within 6 hours prior to IUD insertion * Use of misoprostol within 24 hours prior to IUD insertion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Visual Analogue Score Measuring Pain | 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure | 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 |
Countries
United States
Participant flow
Recruitment details
July 2010- February 2011, Northwestern Medical Faculty Foundation
Participants by arm
| Arm | Count |
|---|---|
| Paracervical Block | 26 |
| No Paracervical Block | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | No Paracervical Block | Paracervical Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 26 Participants | 50 Participants |
| Age Continuous | 33.2 years STANDARD_DEVIATION 6.2 | 31.9 years STANDARD_DEVIATION 5.9 | 32.6 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 24 participants | 26 participants | 50 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Paracervical Block | Median Visual Analogue Score Measuring Pain | 2) Tenaculum Placement | 12 units on a scale | Full Range 21.8 |
| Paracervical Block | Median Visual Analogue Score Measuring Pain | 4) IUD insertion | 24 units on a scale | Full Range 35 |
| Paracervical Block | Median Visual Analogue Score Measuring Pain | 3) Paracervical Block administration | 40 units on a scale | Full Range 29.3 |
| Paracervical Block | Median Visual Analogue Score Measuring Pain | 5) 5 minutes post procedure | 12 units on a scale | Full Range 25.7 |
| Paracervical Block | Median Visual Analogue Score Measuring Pain | 1) Speculum Placement | 12 units on a scale | Full Range 13.1 |
| No Paracervical Block | Median Visual Analogue Score Measuring Pain | 5) 5 minutes post procedure | 17 units on a scale | Full Range 18.4 |
| No Paracervical Block | Median Visual Analogue Score Measuring Pain | 1) Speculum Placement | 8.5 units on a scale | Full Range 12.9 |
| No Paracervical Block | Median Visual Analogue Score Measuring Pain | 2) Tenaculum Placement | 28 units on a scale | Full Range 16.2 |
| No Paracervical Block | Median Visual Analogue Score Measuring Pain | 3) Paracervical Block administration | NA units on a scale | — |
| No Paracervical Block | Median Visual Analogue Score Measuring Pain | 4) IUD insertion | 62 units on a scale | Full Range 27.5 |