Trial Outcomes & Findings for Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section (NCT NCT03383588)
NCT ID: NCT03383588
Last Updated: 2020-01-13
Results Overview
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
4-24 hours post operative
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
Bupivacaine 0.25%
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
|
Bupivacaine 0.25% + Epinephrine
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
|
Saline Solution
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section
Baseline characteristics by cohort
| Measure |
Bupivacaine 0.25%
n=8 Participants
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
|
Bupivacaine 0.25% + Epinephrine
n=9 Participants
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
|
Saline Solution
n=9 Participants
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
34 years
n=7 Participants
|
29 years
n=5 Participants
|
31 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Estimated Blood Loss (EBL)
|
900 ml of blood
n=5 Participants
|
855 ml of blood
n=7 Participants
|
744 ml of blood
n=5 Participants
|
830 ml of blood
n=4 Participants
|
PRIMARY outcome
Timeframe: 4-24 hours post operativePopulation: all patients
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
Outcome measures
| Measure |
Bupivacaine 0.25%
n=8 Participants
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
|
Bupivacaine 0.25% + Epinephrine
n=9 Participants
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
|
Saline Solution
n=9 Participants
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
|
|---|---|---|---|
|
Amount of Supplemental Oxycodone Used
|
19 mg of supplemental oxycodone
Interval 10.0 to 30.0
|
25 mg of supplemental oxycodone
Interval 15.0 to 40.0
|
23 mg of supplemental oxycodone
Interval 10.0 to 40.0
|
Adverse Events
Bupivacaine 0.25%
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine 0.25% + Epinephrine
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Solution
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine 0.25%
n=8 participants at risk
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
|
Bupivacaine 0.25% + Epinephrine
n=9 participants at risk
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
|
Saline Solution
n=9 participants at risk
standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Large intraoperative blood loss
|
0.00%
0/8 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
0.00%
0/9 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
11.1%
1/9 • Number of events 1 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
|
Hepatobiliary disorders
Postpartum re-admission to hospital (not OBGYN related)
|
0.00%
0/8 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
11.1%
1/9 • Number of events 1 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
0.00%
0/9 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum readmission to hospital (OBGYN related)
|
12.5%
1/8 • Number of events 1 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
0.00%
0/9 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
0.00%
0/9 • The participants were followed for a period of 6 months after initial date of recruitment for adverse events via medical record review
Does not differ
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place