Trial Outcomes & Findings for Cervical Lidocaine for Intrauterine Device Insertion Pain (NCT NCT01411995)
NCT ID: NCT01411995
Last Updated: 2018-03-09
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Immediately following IUD insertion
Results posted on
2018-03-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Failed IUD insertion
|
0
|
1
|
Baseline Characteristics
Cervical Lidocaine for Intrauterine Device Insertion Pain
Baseline characteristics by cohort
| Measure |
2% Lidocaine Gel
n=100 Participants
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
|
Water Based Lubricant
n=99 Participants
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
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
99 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
BMI
Less than 18.5
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
BMI
18.5-25
|
45 participants
n=5 Participants
|
41 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
BMI
25.1-30.0
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
BMI
greater than 30.0
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Parity
0
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Parity
1-2
|
42 participants
n=5 Participants
|
38 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Parity
greater than or equal to 3
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Education
Less than or equal to HS
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Education
Some College
|
52 participants
n=5 Participants
|
40 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Education
College graduate
|
33 participants
n=5 Participants
|
41 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
History of abortion
No
|
59 participants
n=5 Participants
|
67 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
History of abortion
Yes
|
41 participants
n=5 Participants
|
32 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
IUD type
LNG-IUD
|
77 participants
n=5 Participants
|
75 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
IUD type
Cu-IUD
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Clinician inserter
Physician
|
46 participants
n=5 Participants
|
44 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Clinician inserter
Nurse Practioner
|
48 participants
n=5 Participants
|
46 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Clinician inserter
Resident
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following IUD insertionUsing 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)
Outcome measures
| Measure |
2% Lidocaine Gel
n=100 Participants
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
|
Water Based Lubricant
n=99 Participants
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
|
|---|---|---|
|
Pain Score Assessed Immediately Following IUD Insertion
|
5 units on visual analog scale
Interval 0.0 to 10.0
|
6 units on visual analog scale
Interval 0.0 to 10.0
|
Adverse Events
2% Lidocaine Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Water Based Lubricant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Colleen McNicholas
Washington University School of Medicine
Phone: 314-747-1331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place