Trial Outcomes & Findings for Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy (NCT NCT04032327)
NCT ID: NCT04032327
Last Updated: 2021-11-18
Results Overview
Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Subjects will be asked to provide numerical values on postoperative day 1.
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
Plain Bupivacaine
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The two populations were analyzed separately.
Baseline characteristics by cohort
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Plain Bupivacaine
|
49.5 years
n=60 Participants • The two populations were analyzed separately.
|
—
|
49.5 years
n=60 Participants • The two populations were analyzed separately.
|
|
Age, Continuous
Exparel Plus Plain Bupivacaine
|
—
|
51.0 years
n=60 Participants • The two populations were analyzed separately.
|
51.0 years
n=60 Participants • The two populations were analyzed separately.
|
|
Sex: Female, Male
Female
|
60 Participants
n=60 Participants
|
60 Participants
n=60 Participants
|
120 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=60 Participants
|
9 Participants
n=60 Participants
|
16 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=60 Participants
|
48 Participants
n=60 Participants
|
94 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
8 Participants
n=120 Participants
|
|
Body Mass Index
Plain Bupivacaine
|
26.1 kg/m^2
n=60 Participants • The two populations were analyzed separately.
|
—
|
26.1 kg/m^2
n=60 Participants • The two populations were analyzed separately.
|
|
Body Mass Index
Exparel plus plain bupivacaine
|
—
|
25.9 kg/m^2
n=60 Participants • The two populations were analyzed separately.
|
25.9 kg/m^2
n=60 Participants • The two populations were analyzed separately.
|
|
Gravidity
Plain Bupivacaine
|
3 pregnancies
n=60 Participants • The two populations were analyzed separately.
|
—
|
3 pregnancies
n=60 Participants • The two populations were analyzed separately.
|
|
Gravidity
Exparel plus plain bupivacaine
|
—
|
3 pregnancies
n=60 Participants • The two populations were analyzed separately.
|
3 pregnancies
n=60 Participants • The two populations were analyzed separately.
|
|
Parity
Plain Bupivacaine
|
2 births
n=60 Participants • The two populations were analyzed separately.
|
—
|
2 births
n=60 Participants • The two populations were analyzed separately.
|
|
Parity
Exparel plus plain bupivacaine
|
—
|
3 births
n=60 Participants • The two populations were analyzed separately.
|
3 births
n=60 Participants • The two populations were analyzed separately.
|
|
colpopexy
none
|
12 Participants
n=60 Participants
|
9 Participants
n=60 Participants
|
21 Participants
n=120 Participants
|
|
colpopexy
laparoscopic
|
32 Participants
n=60 Participants
|
31 Participants
n=60 Participants
|
63 Participants
n=120 Participants
|
|
colpopexy
vaginal
|
16 Participants
n=60 Participants
|
20 Participants
n=60 Participants
|
36 Participants
n=120 Participants
|
|
hysterectomy
none
|
21 Participants
n=60 Participants
|
25 Participants
n=60 Participants
|
46 Participants
n=120 Participants
|
|
hysterectomy
laparoscopic
|
30 Participants
n=60 Participants
|
22 Participants
n=60 Participants
|
52 Participants
n=120 Participants
|
|
hysterectomy
vaginal
|
9 Participants
n=60 Participants
|
13 Participants
n=60 Participants
|
22 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Subjects will be asked to provide numerical values on postoperative day 1.Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively
|
2 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Subjects will be asked to provide numerical values on postoperative day 2.Patients will be asked on postoperative day (POD) 2 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively
|
3 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Subjects will be asked to provide numerical values on postoperative day 3.Patients will be asked on postoperative day (POD) 3 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively
|
3 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)Calculate total postoperative ibuprofen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of ibuprofen utilized at home through postoperative day #3
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home
|
3600 milligrams
Interval 2400.0 to 4800.0
|
2400 milligrams
Interval 0.0 to 4050.0
|
SECONDARY outcome
Timeframe: Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)Calculate total postoperative acetaminophen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of acetaminophen utilized at home through postoperative day #3
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home
|
4000 milligrams
Interval 2110.0 to 5930.0
|
3250 milligrams
Interval 1300.0 to 4550.0
|
SECONDARY outcome
Timeframe: Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized)Calculate total postoperative opioid medications used while inpatient and perform pill counts on postoperative days 1, 2, 3 (done via a phone call or inpatient). This will allow calculation of total amount of opioid pain medications utilized through postoperative day #3
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3)
|
45.0 morphine milligram equivalents
Interval 22.5 to 118.0
|
57.1 morphine milligram equivalents
Interval 30.0 to 93.5
|
SECONDARY outcome
Timeframe: Postoperative active voiding trial on postoperative day 1.Investigators will record in patients passed active voiding trail prior to discharge home.
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
|
82 percentage passed
|
72 percentage passed
|
SECONDARY outcome
Timeframe: Postoperatively up to day 3Investigators will record in patients have had a bowel movement within the first three days postoperatively.
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
|
71.6 percentage of patients
|
73.3 percentage of patients
|
SECONDARY outcome
Timeframe: Subjects will be asked to provide numerical value on postoperative day 3.Investigators will ask patients "how is your vaginal pain impacting your ACTIVITY (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Impact of Vaginal Pain Scores on Quality of Life Measures (ACTIVITY) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
|
3.5 score on a scale
Interval 0.25 to 6.0
|
3 score on a scale
Interval 0.5 to 5.0
|
SECONDARY outcome
Timeframe: Subjects will be asked to provide numerical value on postoperative day 3.Investigators will ask patients "how is your vaginal pain impacting your SLEEP (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Impact of Vaginal Pain Scores on Quality of Life Measure (SLEEP) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
|
0.500 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Subjects will be asked to provide numerical value on postoperative day 3.Investigators will ask patients "how is your vaginal pain impacting your MOOD (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Impact of Vaginal Pain Scores on Quality of Life Measure (MOOD) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
|
1 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Subjects will be asked to provide numerical value on postoperative day 3.Investigators will ask patients "how is your vaginal pain impacting your STRESS (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Outcome measures
| Measure |
Plain Bupivacaine
n=60 Participants
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 Participants
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Impact of Vaginal Pain Scores on Quality of Life Measure (STRESS) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
|
0 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
Adverse Events
Plain Bupivacaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Exparel Plus Plain Bupivacaine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Plain Bupivacaine
n=60 participants at risk
20 mL of 0.25% plain bupivacaine
Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
|
Exparel Plus Plain Bupivacaine
n=60 participants at risk
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Postoperative sensory numbness/tingling in the lower extremities
|
5.0%
3/60 • Number of events 3 • entirety of the study (AUG2018-AUG2020); patients were followed out to 6 weeks postoperatively
|
6.7%
4/60 • Number of events 4 • entirety of the study (AUG2018-AUG2020); patients were followed out to 6 weeks postoperatively
|
Additional Information
Katherine L Dengler, MD
Walter Reed National Military Medical Center
Phone: 301-400-2468
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place