Pain
Conditions
Keywords
intrauterine device, pain, lidocaine gel
Brief summary
The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.
Detailed description
Double blind randomized controlled trial. Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement
Interventions
DRUG2% lidocaine gel
3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion
3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-45 yrs * selecting intrauterine device contraception * able and willing to consent
Exclusion criteria
* non-English speaking * current intrauterine device use * expulsion of intrauterine device within 2 weeks * allergy to lidocaine or water based lubricant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Assessed Immediately Following IUD Insertion | Immediately following IUD insertion | Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required. Range: 0-10 (0= no pain, 10=worst pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2% Lidocaine Gel Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal
2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion | 100 |
| Water Based Lubricant Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal
Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion | 99 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed IUD insertion | 0 | 1 |
Baseline characteristics
| Characteristic | Water Based Lubricant | Total | 2% Lidocaine Gel |
|---|---|---|---|
| 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 | 99 Participants | 199 Participants | 100 Participants |
| BMI 18.5-25 | 41 participants | 86 participants | 45 participants |
| BMI 25.1-30.0 | 28 participants | 56 participants | 28 participants |
| BMI greater than 30.0 | 28 participants | 52 participants | 24 participants |
| BMI Less than 18.5 | 2 participants | 5 participants | 3 participants |
| Clinician inserter Nurse Practioner | 46 participants | 94 participants | 48 participants |
| Clinician inserter Physician | 44 participants | 90 participants | 46 participants |
| Clinician inserter Resident | 9 participants | 15 participants | 6 participants |
| Education College graduate | 41 participants | 74 participants | 33 participants |
| Education Less than or equal to HS | 18 participants | 33 participants | 15 participants |
| Education Some College | 40 participants | 92 participants | 52 participants |
| History of abortion No | 67 participants | 126 participants | 59 participants |
| History of abortion Yes | 32 participants | 73 participants | 41 participants |
| IUD type Cu-IUD | 24 participants | 47 participants | 23 participants |
| IUD type LNG-IUD | 75 participants | 152 participants | 77 participants |
| Parity 0 | 50 participants | 100 participants | 50 participants |
| Parity 1-2 | 38 participants | 80 participants | 42 participants |
| Parity greater than or equal to 3 | 11 participants | 19 participants | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 75 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 105 Participants | 54 Participants |
| Region of Enrollment United States | 99 participants | 199 participants | 100 participants |
| Sex: Female, Male Female | 99 Participants | 199 Participants | 100 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 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Pain Score Assessed Immediately Following IUD Insertion
Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required. Range: 0-10 (0= no pain, 10=worst pain)
Time frame: Immediately following IUD insertion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2% Lidocaine Gel | Pain Score Assessed Immediately Following IUD Insertion | 5 units on visual analog scale |
| Water Based Lubricant | Pain Score Assessed Immediately Following IUD Insertion | 6 units on visual analog scale |