Trial Outcomes & Findings for Self-Administered Lidocaine Gel for Pain Management With IUD Insertion (NCT NCT02738203)
NCT ID: NCT02738203
Last Updated: 2019-06-06
Results Overview
Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
220 participants
Primary outcome timeframe
0-3 minutes after procedure completed
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
Experimental, IUD Insertion Group
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
|
Overall Study
COMPLETED
|
108
|
107
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Experimental, IUD Insertion Group
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
|---|---|---|
|
Overall Study
Failed IUD Insertion
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Self-Administered Lidocaine Gel for Pain Management With IUD Insertion
Baseline characteristics by cohort
| Measure |
Experimental, IUD Insertion Group
n=108 Participants
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
n=107 Participants
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
n=5 Participants
|
27 years
n=7 Participants
|
28 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
107 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Previous Intrauterine Device Insertion
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-3 minutes after procedure completedPopulation: Per protocol analysis
Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Outcome measures
| Measure |
Experimental, IUD Insertion Group
n=108 Participants
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
n=107 Participants
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
|---|---|---|
|
(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion
|
65 score on a scale
Interval 1.0 to 99.0
|
59 score on a scale
Interval 5.0 to 100.0
|
SECONDARY outcome
Timeframe: 30 Minutes prior to procedurePopulation: Per protocol analysis
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Outcome measures
| Measure |
Experimental, IUD Insertion Group
n=108 Participants
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
n=107 Participants
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
|---|---|---|
|
Anticipated Pain as Measured by a Visual Analog Scale
|
60 score on a scale
Interval 1.0 to 87.0
|
59 score on a scale
Interval 6.0 to 94.0
|
SECONDARY outcome
Timeframe: Immediately prior to procedure; upon arrival to procedure roomPopulation: Per protocol analysis
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Outcome measures
| Measure |
Experimental, IUD Insertion Group
n=108 Participants
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
n=107 Participants
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
|---|---|---|
|
Baseline Pain as Measured by a Visual Analog Scale
|
2 score on a scale
Interval 0.0 to 77.0
|
2 score on a scale
Interval 0.0 to 22.0
|
SECONDARY outcome
Timeframe: IntraoperativePopulation: Per protocol analysis
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Outcome measures
| Measure |
Experimental, IUD Insertion Group
n=108 Participants
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
n=107 Participants
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
|---|---|---|
|
Pain After Speculum Placement as Measured by a Visual Analog Scale
|
7 score on a scale
Interval 0.0 to 81.0
|
11 score on a scale
Interval 0.0 to 80.0
|
SECONDARY outcome
Timeframe: IntraoperativePopulation: Per protocol analysis
Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Outcome measures
| Measure |
Experimental, IUD Insertion Group
n=108 Participants
If the subject is assigned to the experimental group (vaginal lidocaine jelly):
She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
|
Control, IUD Insertion Group
n=107 Participants
If the subject is assigned to the control group (sterile, surgical lubricant jelly):
•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.
Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
|
|---|---|---|
|
Pain After Tenaculum Placement as Measured by a Visual Analog Scale
|
30 score on a scale
Interval 0.0 to 86.0
|
38 score on a scale
Interval 0.0 to 84.0
|
Adverse Events
Experimental, IUD Insertion Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control, IUD Insertion Group
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
Research Manager
Stanford University, Department of OB/GYN
Phone: 6507211562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place