Trial Outcomes & Findings for Paracervical Block for Pain Associated With Laminaria Insertion (NCT NCT02454296)
NCT ID: NCT02454296
Last Updated: 2017-04-14
Results Overview
We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Measured within 10 seconds after placement of laminaria
Results posted on
2017-04-14
Participant Flow
Participants recruited from May 2015 to Dec 2015 at two of the faculty practice offices of the University of Hawaii Department of OB/gyn.
Participant milestones
| Measure |
Paracervical Block With Lidocaine
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
|
Sham Paracervical Block
A sham block will be done prior to the placement of laminaria using a capped needle
Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paracervical Block for Pain Associated With Laminaria Insertion
Baseline characteristics by cohort
| Measure |
Paracervical Block Group
n=20 Participants
Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
|
Sham Block Group
n=21 Participants
Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.80 years
STANDARD_DEVIATION 6.12 • n=5 Participants
|
29.81 years
STANDARD_DEVIATION 6.92 • n=7 Participants
|
27.85 years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
|
Sex/Gender, Customized
Females
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latina
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured within 10 seconds after placement of laminariaWe asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.
Outcome measures
| Measure |
Paracervical Block With Lidocaine
n=20 Participants
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
|
Sham Paracervical Block
n=21 Participants
A sham block will be done prior to the placement of laminaria using a capped needle
Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes
|
|---|---|---|
|
Pain After Placement of Laminaria (100 mm Visual Analog Scale)
|
13 units on a scale (100 mm VAS)
Interval 2.0 to 39.0
|
54 units on a scale (100 mm VAS)
Interval 27.0 to 61.0
|
SECONDARY outcome
Timeframe: 15 minutes post-operativelyPatients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied
Outcome measures
| Measure |
Paracervical Block With Lidocaine
n=20 Participants
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
|
Sham Paracervical Block
n=21 Participants
A sham block will be done prior to the placement of laminaria using a capped needle
Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes
|
|---|---|---|
|
Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)
|
95 units on a scale (100 mm VAS)
Interval 78.0 to 100.0
|
70 units on a scale (100 mm VAS)
Interval 44.0 to 90.0
|
SECONDARY outcome
Timeframe: Within 10 seconds after receiving paracervical or sham blockParticipants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.
Outcome measures
| Measure |
Paracervical Block With Lidocaine
n=20 Participants
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
|
Sham Paracervical Block
n=21 Participants
A sham block will be done prior to the placement of laminaria using a capped needle
Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes
|
|---|---|---|
|
Paracervical or Sham Block Pain
|
14 units on a scale (100 mm VAS)
Interval 6.0 to 31.0
|
27 units on a scale (100 mm VAS)
Interval 6.0 to 41.0
|
Adverse Events
Paracervical Block With Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place