Trial Outcomes & Findings for Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery (NCT NCT00804609)
NCT ID: NCT00804609
Last Updated: 2017-10-12
Results Overview
The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose
Results posted on
2017-10-12
Participant Flow
30 patients enrolled at Stanford clinics
The patients were divided into 2 groups: group E (epidural) consisted of patients undergoing elective cesarean delivery or undergoing nonelective cesarean delivery during labor. Group SE (Spinal-Epidural) consisted of patients undergoing an elective cesarean delivery. Patients received an anesthetic consisting of a combined spinal-epidural.
Participant milestones
| Measure |
Epidural DepoDur Following Epidural Lidocaine Administration
Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
|
Epidural DepoDur Following Spinal Anesthetic
Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Epidural DepoDur Following Epidural Lidocaine Administration
n=15 Participants
Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
DepoDur: All participant underwent cesarean delivery. An epidural "top-up" anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.
Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration.
|
Epidural DepoDur Following Spinal Anesthetic
n=15 Participants
Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
DepoDur: Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.
Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 5 • n=5 Participants
|
36 years
STANDARD_DEVIATION 3 • n=7 Participants
|
34 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-doseThe primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.
Outcome measures
| Measure |
Epidural DepoDur Following Epidural Lidocaine Administration
n=15 Participants
Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
|
Epidural DepoDur Following Spinal Anesthetic
n=14 Participants
Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)
|
11.1 ng/mL
Standard Deviation 4.9
|
8.3 ng/mL
Standard Deviation 7.1
|
Adverse Events
Epidural DepoDur Following Epidural Lidocaine Administration
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Epidural DepoDur Following Spinal Anesthetic
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epidural DepoDur Following Epidural Lidocaine Administration
n=15 participants at risk
Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
|
Epidural DepoDur Following Spinal Anesthetic
n=14 participants at risk
Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
|
|---|---|---|
|
Vascular disorders
hypotension ( 25% reduction in systolic blood pressure from baseline)
|
0.00%
0/15
Serious adverse events were not collected. None were anticipated.
|
7.1%
1/14 • Number of events 1
Serious adverse events were not collected. None were anticipated.
|
|
Respiratory, thoracic and mediastinal disorders
supplemental oxygen
|
40.0%
6/15 • Number of events 6
Serious adverse events were not collected. None were anticipated.
|
0.00%
0/14
Serious adverse events were not collected. None were anticipated.
|
|
Respiratory, thoracic and mediastinal disorders
oxygen desaturations (defined as oxygen saturations 93%)
|
33.3%
5/15 • Number of events 5
Serious adverse events were not collected. None were anticipated.
|
0.00%
0/14
Serious adverse events were not collected. None were anticipated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place