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Trial Outcomes & Findings for Paracervical Block Before Intrauterine Device (IUD) Insertion (NCT NCT01207401)

NCT ID: NCT01207401

Last Updated: 2013-06-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure

Results posted on

2013-06-10

Participant Flow

July 2010- February 2011, Northwestern Medical Faculty Foundation

Participant milestones

Participant milestones
Measure
Paracervical Block
IUD insertion after a 10 cc 1% Lidocaine administeration at 4 o'clock and 8 o'clock at the cervical-vaginal mucosa.
No Paracervical Block
IUD insertion with no lidocaine injection
Overall Study
STARTED
26
24
Overall Study
COMPLETED
26
24
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paracervical Block Before Intrauterine Device (IUD) Insertion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Paracervical Block
n=26 Participants
No Paracervical Block
n=24 Participants
Total
n=50 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
26 Participants
n=5 Participants
24 Participants
n=7 Participants
50 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
31.9 years
STANDARD_DEVIATION 5.9 • n=5 Participants
33.2 years
STANDARD_DEVIATION 6.2 • n=7 Participants
32.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male
Female
26 Participants
n=5 Participants
24 Participants
n=7 Participants
50 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
26 participants
n=5 Participants
24 participants
n=7 Participants
50 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Paracervical Block
n=26 Participants
No Paracervical Block
n=24 Participants
Median Visual Analogue Score Measuring Pain
4) IUD insertion
24 units on a scale
Full Range 35.0 • Interval 0.0 to 99.0
62 units on a scale
Full Range 27.5 • Interval 2.0 to 89.0
Median Visual Analogue Score Measuring Pain
5) 5 minutes post procedure
12 units on a scale
Full Range 25.7 • Interval 0.0 to 97.0
17 units on a scale
Full Range 18.4 • Interval 1.0 to 66.0
Median Visual Analogue Score Measuring Pain
1) Speculum Placement
12 units on a scale
Full Range 13.1 • Interval 0.0 to 55.0
8.5 units on a scale
Full Range 12.9 • Interval 1.0 to 52.0
Median Visual Analogue Score Measuring Pain
2) Tenaculum Placement
12 units on a scale
Full Range 21.8 • Interval 0.0 to 98.0
28 units on a scale
Full Range 16.2 • Interval 0.0 to 57.0
Median Visual Analogue Score Measuring Pain
3) Paracervical Block administration
40 units on a scale
Full Range 29.3 • Interval 2.0 to 94.0
NA units on a scale
VAS not administered because Group did not receive paracervical block

Adverse Events

Paracervical Block

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Paracervical Block

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. Sheila Krishnan Mody

University of California, San Diego

Phone: (619)543-6777

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place