Trial Outcomes & Findings for Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion (NCT NCT04254081)
NCT ID: NCT04254081
Last Updated: 2023-08-01
Results Overview
Median pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale at the time of osmotic dilator insertion
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
57 participants
Primary outcome timeframe
Assessed immediately after last dilator inserted
Results posted on
2023-08-01
Participant Flow
This is a multi-site, randomized, double-blind controlled trial conducted from May 2020-May 2021. Participants presenting for dilation and evacuation who required osmotic dilators for cervical preparation were randomized 1:1 to receive a 1% buffered lidocaine PCB or a 1% buffered lidocaine + 0.15mg buprenorphine PCB.
Participant milestones
| Measure |
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
|
1% Lidocaine Paracervical Block
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion
Baseline characteristics by cohort
| Measure |
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
n=28 Participants
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
|
1% Lidocaine Paracervical Block
n=29 Participants
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
|
Total
n=57 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
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 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
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latina
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other or multiracial
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed immediately after last dilator insertedMedian pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale at the time of osmotic dilator insertion
Outcome measures
| Measure |
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
n=28 Participants
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
|
1% Lidocaine Paracervical Block
n=29 Participants
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
|
|---|---|---|
|
Pain Score at the Time of Osmotic Dilator Insertion
|
3.5 score on a scale
Interval 1.0 to 6.0
|
4.0 score on a scale
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: 2 hours after osmotic dilator insertionMedian pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 2 hours after osmotic dilator insertion assessed via text message
Outcome measures
| Measure |
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
n=28 Participants
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
|
1% Lidocaine Paracervical Block
n=29 Participants
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
|
|---|---|---|
|
Pain Score 2 Hours After Osmotic Dilator Insertion
|
3 score on a scale
Interval 1.0 to 5.0
|
3.5 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 1 hour after osmotic dilator insertionMedian pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 1 hour after osmotic dilator insertion assessed via text message
Outcome measures
| Measure |
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
n=28 Participants
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
|
1% Lidocaine Paracervical Block
n=29 Participants
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
|
|---|---|---|
|
Pain Score 1 Hour After Osmotic Dilator Insertion
|
2 score on a scale
Interval 1.0 to 3.0
|
3.5 score on a scale
Interval 1.75 to 5.25
|
SECONDARY outcome
Timeframe: 6 hours after osmotic dilator insertionMedian pain score on a 0 (no pain) to 10 (worst pain) numeric rating scale 6 hours after osmotic dilator insertion assessed via text message
Outcome measures
| Measure |
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
n=28 Participants
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
|
1% Lidocaine Paracervical Block
n=29 Participants
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
|
|---|---|---|
|
Pain Score 6 Hours After Osmotic Dilator Insertion
|
3 score on a scale
Interval 1.75 to 5.25
|
3 score on a scale
Interval 0.5 to 4.5
|
SECONDARY outcome
Timeframe: Morning of D&E procedure: after check-in, before D&ETo determine patient satisfaction with pain control during and after osmotic dilator insertion. This was assessed on the morning of D\&E procedure. Participants following question and rated responses on a Likert scale: What was your overall satisfaction with the amount of pain control that you had during the procedure?
Outcome measures
| Measure |
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
n=28 Participants
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine
Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
|
1% Lidocaine Paracervical Block
n=29 Participants
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate
Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
|
|---|---|---|
|
Overall Satisfaction Scores
Very Satisfied
|
14 Participants
|
13 Participants
|
|
Overall Satisfaction Scores
Satisfied
|
9 Participants
|
14 Participants
|
|
Overall Satisfaction Scores
Slightly Satisfied
|
3 Participants
|
0 Participants
|
|
Overall Satisfaction Scores
Slightly dissatisfied
|
2 Participants
|
1 Participants
|
|
Overall Satisfaction Scores
Dissatisfied
|
0 Participants
|
0 Participants
|
|
Overall Satisfaction Scores
Very dissatisfied
|
0 Participants
|
1 Participants
|
Adverse Events
Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1% Lidocaine 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
UCSD Family Planning Research
University of California, San Diego
Phone: (858) 329-4464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place