Trial Outcomes & Findings for EXPAREL for Minimally Invasive Supracervical Hysterectomies (NCT NCT03769714)
NCT ID: NCT03769714
Last Updated: 2024-01-09
Results Overview
Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).at 12 hours postoperatively
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
12 hours after surgery
Results posted on
2024-01-09
Participant Flow
Participant milestones
| Measure |
Saline Solution for Injection
Group A (control, n=30) to receive 20ml of saline while prepping. The syringe will covered as to disguise the contents of the syringe.
Saline Solution for Injection: Injection of 20mL of 0.9%Normal Saline
|
Exparel
Group B (study, n=30) to receive 20ml of liposomal bupivacaine (EXPAREL) into the stroma of the cervix at the 4 and 8 o'clock positions (innervation insertion points of the cervix).
Exparel: Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EXPAREL for Minimally Invasive Supracervical Hysterectomies
Baseline characteristics by cohort
| Measure |
Saline Solution for Injection
n=30 Participants
Group A (control, n=30) to receive 20ml of saline while prepping. The syringe will covered as to disguise the contents of the syringe.
Saline Solution for Injection: Injection of 20mL of 0.9%Normal Saline
|
Exparel
n=30 Participants
Group B (study, n=30) to receive 20ml of liposomal bupivacaine (EXPAREL) into the stroma of the cervix at the 4 and 8 o'clock positions (innervation insertion points of the cervix).
Exparel: Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.
|
Total
n=60 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
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 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
|
47 years
n=5 Participants
|
45 years
n=7 Participants
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hours after surgeryParticipant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).at 12 hours postoperatively
Outcome measures
| Measure |
Saline Solution for Injection
n=27 Participants
Group A (control, n=30) to receive 20ml of saline while prepping. The syringe will covered as to disguise the contents of the syringe.
Saline Solution for Injection: Injection of 20mL of 0.9%Normal Saline
|
Exparel
n=28 Participants
Group B (study, n=30) to receive 20ml of liposomal bupivacaine (EXPAREL) into the stroma of the cervix at the 4 and 8 o'clock positions (innervation insertion points of the cervix).
Exparel: Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.
|
|---|---|---|
|
Pain at 12 Hours
|
3.9 score on a scale
Standard Deviation 3.1
|
3.7 score on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 48 hours after surgeyParticipant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).at 48 hours postoperatively
Outcome measures
| Measure |
Saline Solution for Injection
n=24 Participants
Group A (control, n=30) to receive 20ml of saline while prepping. The syringe will covered as to disguise the contents of the syringe.
Saline Solution for Injection: Injection of 20mL of 0.9%Normal Saline
|
Exparel
n=26 Participants
Group B (study, n=30) to receive 20ml of liposomal bupivacaine (EXPAREL) into the stroma of the cervix at the 4 and 8 o'clock positions (innervation insertion points of the cervix).
Exparel: Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.
|
|---|---|---|
|
Pain at 48 Hours
|
3.2 score on a scale
Standard Deviation 2.2
|
3.9 score on a scale
Standard Deviation 1.8
|
Adverse Events
Saline Solution for Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exparel
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