Trial Outcomes & Findings for Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses (NCT NCT02340806)
NCT ID: NCT02340806
Last Updated: 2019-11-26
Results Overview
Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
epidural placement to delivery, up to 36 hours.
Results posted on
2019-11-26
Participant Flow
220 patients met inclusion criteria.
Participant milestones
| Measure |
High Rate Bolus (CADD-Solis Pump)
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
112
|
|
Overall Study
COMPLETED
|
102
|
108
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
High Rate Bolus (CADD-Solis Pump)
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
epidural catheter replaced
|
2
|
1
|
|
Overall Study
history of chronic pain medication
|
1
|
0
|
|
Overall Study
re-dose < 90 min of CSE
|
1
|
3
|
Baseline Characteristics
24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
Baseline characteristics by cohort
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=102 Participants
|
31 years
n=108 Participants
|
31 years
n=210 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=102 Participants
|
108 Participants
n=108 Participants
|
210 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=102 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=102 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=102 Participants
|
9 Participants
n=108 Participants
|
14 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=102 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=102 Participants
|
7 Participants
n=108 Participants
|
12 Participants
n=210 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=102 Participants
|
79 Participants
n=108 Participants
|
165 Participants
n=210 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=102 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=102 Participants
|
13 Participants
n=108 Participants
|
19 Participants
n=210 Participants
|
|
Gestational Age (weeks)
|
40 Weeks
n=102 Participants
|
40 Weeks
n=108 Participants
|
40 Weeks
n=210 Participants
|
|
Body Mass Index (kg/m2)
|
29 (kg/m2)
n=102 Participants
|
29 (kg/m2)
n=108 Participants
|
29 (kg/m2)
n=210 Participants
|
|
Labor Type
Spontaneous Labor
|
31 Participants
n=102 Participants
|
35 Participants
n=108 Participants
|
66 Participants
n=210 Participants
|
|
Labor Type
Induction of Labor
|
71 Participants
n=102 Participants
|
73 Participants
n=108 Participants
|
144 Participants
n=210 Participants
|
|
Cervical dilation at request for epidural (cm)
|
2 centimeters
n=102 Participants
|
2 centimeters
n=108 Participants
|
2 centimeters
n=210 Participants
|
|
VAS (visual analog scale)
|
75 units on a scale
n=102 Participants
|
73 units on a scale
n=108 Participants
|
74 units on a scale
n=210 Participants
|
|
Mode of delivery
Vaginal Delivery
|
69 Participants
n=102 Participants
|
71 Participants
n=108 Participants
|
140 Participants
n=210 Participants
|
|
Mode of delivery
Assisted Vaginal Delivery
|
9 Participants
n=102 Participants
|
13 Participants
n=108 Participants
|
22 Participants
n=210 Participants
|
|
Mode of delivery
Cesarean Delivery
|
24 Participants
n=102 Participants
|
24 Participants
n=108 Participants
|
48 Participants
n=210 Participants
|
|
Indication for Cesarean delivery
Arrest of dilation
|
7 Participants
n=24 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
14 Participants
n=24 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
21 Participants
n=48 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
|
Indication for Cesarean delivery
Arrest of descent
|
8 Participants
n=24 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
5 Participants
n=24 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
13 Participants
n=48 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
|
Indication for Cesarean delivery
Fetal Intolerance
|
9 Participants
n=24 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
5 Participants
n=24 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
14 Participants
n=48 Participants • 24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.
|
PRIMARY outcome
Timeframe: epidural placement to delivery, up to 36 hours.Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Number of Participants Who Experienced Breakthrough Pain.
|
37 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: epidural placement to delivery, up to 36 hours.Total bupivacaine amount (milligrams/hour mg/h) via pump and provider administered supplemental boluses
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Total Bupivacaine Consumption Per Hour of Labor Analgesia
|
9.9 milligrams per hour
Interval 8.1 to 11.4
|
10.8 milligrams per hour
Interval 8.6 to 11.4
|
SECONDARY outcome
Timeframe: epidural placement to delivery, up to 36 hours.Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Total Number of Requested PCEA Boluses
|
14 Doses
Interval 6.0 to 27.0
|
17 Doses
Interval 10.0 to 31.0
|
SECONDARY outcome
Timeframe: epidural placement to delivery, up to 36 hours.Total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's delivered.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Total Number of Delivered PCEA Boluses
|
9 Doses
Interval 5.0 to 18.0
|
10 Doses
Interval 7.0 to 17.0
|
SECONDARY outcome
Timeframe: epidural placement to delivery, up to 36 hours.The ratio of the total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's requested and PCEA doses delivered.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Ratio of Total Number of PCEA Boluses Requested and Delivered
|
1.4 Ratio
Interval 1.2 to 2.1
|
1.5 Ratio
Interval 1.2 to 2.1
|
SECONDARY outcome
Timeframe: up to 24 hours after deliveryPatients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Satisfaction Scores
|
98 score on a scale (0 poor 100 good)
Interval 86.0 to 100.0
|
98 score on a scale (0 poor 100 good)
Interval 88.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: epidural to first request of redose up to 10 hoursTime to provider administered supplemental boluses measured in minutes
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Time to Provider Administered Supplemental Boluses
|
357 Minutes
Interval 215.0 to 525.0
|
302 Minutes
Interval 148.0 to 559.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: epidural placement to delivery, up to 36 hours.Weighted mean pain score (measured by the area under the VAS (Visual Analog Scale)-time curve calculated using the trapezoidal integration divided by the duration of labor analgesia).Visual Analog Scale is a 100 millimeter scale where 0 is no pain and 100 is worst pain imaginable.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Mean Pain Score
|
9 units on a scale
Interval 3.9 to 17.2
|
6.9 units on a scale
Interval 3.7 to 15.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 2 stages of labor up to 24 hoursThe stage of labor ( first or second) at the time of re-dose request.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Stage of Labor at Re-dose Request
First stage of labor
|
34 Participants
|
40 Participants
|
|
Stage of Labor at Re-dose Request
Second stage of labor
|
3 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: epidural placement to delivery, up to 36 hours.Total number of patients requiring epidural re-doses given by the provider.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
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Number of Participants With Epidural Re-doses
No- redoses
|
59 Participants
|
71 Participants
|
|
Number of Participants With Epidural Re-doses
1 re-dose
|
31 Participants
|
27 Participants
|
|
Number of Participants With Epidural Re-doses
2 re-doses
|
6 Participants
|
5 Participants
|
|
Number of Participants With Epidural Re-doses
3 re-doses
|
6 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours after delivery of babyPatient satisfaction of labor anesthesia using a score of 0 low satisfaction to 100 high satisfaction on a 100 millimeter scale.
Outcome measures
| Measure |
High Rate Bolus (CADD-Solis Pump)
n=102 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
Low Rate Bolus (CADD-Solis Pump)
n=108 Participants
Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.
CADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
|
|---|---|---|
|
Patient Satisfaction of Labor Anesthesia
|
98 score on a scale (0 poor 100 good)
Interval 86.0 to 100.0
|
98 score on a scale (0 poor 100 good)
Interval 88.0 to 100.0
|
Adverse Events
High Rate Bolus (CADD-Solis Pump)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Rate Bolus (CADD-Solis Pump)
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