Trial Outcomes & Findings for Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion (NCT NCT01466491)
NCT ID: NCT01466491
Last Updated: 2019-11-08
Results Overview
To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
332 participants
Primary outcome timeframe
after completion of cervical dilation
Results posted on
2019-11-08
Participant Flow
Participant milestones
| Measure |
4-site Injection
The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
2-site Injection
The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-Site PCB Followed by 3-minute Wait
Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-site PCB Followed by no Wait
Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
83
|
83
|
83
|
|
Overall Study
COMPLETED
|
83
|
80
|
80
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
4-site Injection
The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
2-site Injection
The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-Site PCB Followed by 3-minute Wait
Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-site PCB Followed by no Wait
Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
2
|
0
|
|
Overall Study
Missing Data
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Baseline characteristics by cohort
| Measure |
4-site Injection
n=83 Participants
The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
2-site Injection
n=80 Participants
The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-Site PCB Followed by 3-minute Wait
n=80 Participants
Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-site PCB Followed by no Wait
n=83 Participants
Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
Total
n=326 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
326 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
25.2 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
25.5 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
25.2 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
26.4 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
25.575 years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
326 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=5 Participants
|
80 participants
n=7 Participants
|
80 participants
n=5 Participants
|
83 participants
n=4 Participants
|
326 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: after completion of cervical dilationTo determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation.
Outcome measures
| Measure |
4-site Injection
n=83 Participants
The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
2-site Injection
n=80 Participants
The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-Site PCB Followed by 3-minute Wait
n=80 Participants
Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-site PCB Followed by no Wait
n=83 Participants
Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
|---|---|---|---|---|
|
Patient Perception of Pain
|
60 mm
Standard Deviation 30
|
68 mm
Standard Deviation 21
|
56 mm
Standard Deviation 32
|
63 mm
Standard Deviation 24
|
SECONDARY outcome
Timeframe: up to several hoursDistance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure: * prior to medication (baseline) * after speculum insertion * with placement of PCB * with cervical dilation * with aspiration * 30 minutes post-operatively
Outcome measures
| Measure |
4-site Injection
n=83 Participants
The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
2-site Injection
n=80 Participants
The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-Site PCB Followed by 3-minute Wait
n=80 Participants
Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
4-site PCB Followed by no Wait
n=83 Participants
Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
|
|---|---|---|---|---|
|
Pain Scores Throughout Procedure at Various Time Points
With placement of PCB
|
58.89 mm
Standard Error 2.64
|
55.31 mm
Standard Error 2.69
|
60.0 mm
Standard Error 2.8
|
58.3 mm
Standard Error 2.8
|
|
Pain Scores Throughout Procedure at Various Time Points
Prior to medication (baseline)
|
7.65 mm
Standard Error 1.27
|
4.84 mm
Standard Error 1.30
|
4.2 mm
Standard Error 2.5
|
6 mm
Standard Error 0.9
|
|
Pain Scores Throughout Procedure at Various Time Points
After speculum insertion
|
29.35 mm
Standard Error 2.43
|
27.31 mm
Standard Error 2.47
|
29.3 mm
Standard Error 2.7
|
30.3 mm
Standard Error 2.7
|
|
Pain Scores Throughout Procedure at Various Time Points
With cervical dilation
|
59.76 mm
Standard Error 2.84
|
68.41 mm
Standard Error 2.90
|
55.6 mm
Standard Error 3.1
|
63.2 mm
Standard Error 3.1
|
|
Pain Scores Throughout Procedure at Various Time Points
With aspiration
|
67.75 mm
Standard Error 2.52
|
74.05 mm
Standard Error 2.56
|
72.1 mm
Standard Error 2.6
|
69.4 mm
Standard Error 2.5
|
|
Pain Scores Throughout Procedure at Various Time Points
30 minutes post-operatively
|
26.27 mm
Standard Error 2.56
|
22.37 mm
Standard Error 2.30
|
27.3 mm
Standard Error 2.6
|
24.2 mm
Standard Error 2.5
|
Adverse Events
4-site Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2-site Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4-Site PCB Followed by 3-minute Wait
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4-site PCB Followed by no Wait
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