Trial Outcomes & Findings for Programmed Intermittent Epidural Bolus Time Interval and Injection Volume (NCT NCT00417027)
NCT ID: NCT00417027
Last Updated: 2014-04-14
Results Overview
Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
From initiation of labor analgesia until delivery less than 24 hours
Results posted on
2014-04-14
Participant Flow
Nulliparous women in spontaneous labor were asked to participate shortly after admission to the Labor and Delivery Unit at Prentice Women's Hospital. Immediately following the routine preanesthetic interview, subjects were approached and informed, written consent was obtained.
Participant milestones
| Measure |
2.5 mL Bolused Every 15 Minutes
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
65
|
59
|
|
Overall Study
COMPLETED
|
66
|
60
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
5
|
Reasons for withdrawal
| Measure |
2.5 mL Bolused Every 15 Minutes
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
5
|
5
|
Baseline Characteristics
Programmed Intermittent Epidural Bolus Time Interval and Injection Volume
Baseline characteristics by cohort
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=65 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=59 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
Total
n=190 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
31 years
n=5 Participants
|
30 years
n=7 Participants
|
31 years
n=5 Participants
|
31 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
190 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
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
65 participants
n=7 Participants
|
59 participants
n=5 Participants
|
190 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From initiation of labor analgesia until delivery less than 24 hoursPopulation: per protocal
Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.
Outcome measures
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=60 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=54 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.
|
11.3 mg bupivacaine per hour
Interval 9.5 to 13.6
|
11.1 mg bupivacaine per hour
Interval 9.2 to 13.3
|
10.3 mg bupivacaine per hour
Interval 8.9 to 11.2
|
SECONDARY outcome
Timeframe: Duration of labor analgesiaPopulation: per protocal
The pain burden calculated as the area under the visual analog pain scale (0 to 100 mm) patient self reported assessment of pain. Pain assessment were made at regular intervals during labor and the area under the pain score per time curve was calculated as the pain burden during labor. Greater pain would be indicated by a larger area. Possible range would be 0 for no pain to 100 for severe pain.
Outcome measures
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=60 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=54 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve
|
15 0 to 100 mm per hour
Interval 6.0 to 29.0
|
13 0 to 100 mm per hour
Interval 5.0 to 26.0
|
14 0 to 100 mm per hour
Interval 8.0 to 25.0
|
SECONDARY outcome
Timeframe: Duration of labor analgesiaPopulation: per protocal
The number of attempted self administered bolus doses of epidural analgesia solution for control of pain.
Outcome measures
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=60 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=54 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Patient Controlled Bolus Attempts
|
10 number of bolus attempts
Interval 3.0 to 17.0
|
10 number of bolus attempts
Interval 3.0 to 17.0
|
8 number of bolus attempts
Interval 4.0 to 11.0
|
SECONDARY outcome
Timeframe: Duration of labor analgesiaPopulation: per protocal
Patient controlled bolus of analgesic solution could be requested by activating a button. Bolus were 5ml of the epidural solution (bupivacaine 6.25mg/ml and fentanyl 1.96mgml). Patient requested administrations were allowed every 10 minutes to a maximum of 30 ml of epidural solution per hour.
Outcome measures
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=60 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=54 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered
|
7 participants
Interval 3.0 to 11.0
|
6 participants
Interval 4.0 to 10.0
|
6 participants
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Duration of labor analgesiaOutcome measures
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=60 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=54 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Manual Bolus Doses Administered
0 doses
|
24 participants
|
30 participants
|
27 participants
|
|
Manual Bolus Doses Administered
1 dose
|
23 participants
|
17 participants
|
17 participants
|
|
Manual Bolus Doses Administered
2 doses
|
12 participants
|
11 participants
|
7 participants
|
|
Manual Bolus Doses Administered
3 doses
|
3 participants
|
1 participants
|
1 participants
|
|
Manual Bolus Doses Administered
4 doses
|
4 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 3 hours after initiation of labor analgesiaHighest level of sensory loss to ice 3 hours after initiation of epidural analgesia. Thoracic dermatomes specify the level at which the nerves exit the spinal column. Higher thoracic spread of analgesia suggests greater dispersion of the epidural solution and may correlate with better analgesia. Higher levels are given by lower thoracic vertebral number. For example dermatome 4 has greater spread than dermatome 5.
Outcome measures
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=60 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=54 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
Thoracic dermatome 4
|
6 participants
Interval 7.0 to 4.0
|
5 participants
Interval 7.0 to 5.0
|
5 participants
Interval 7.0 to 5.0
|
|
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
Thoracic dermatome 5
|
11 participants
Interval 8.0 to 6.0
|
12 participants
Interval 9.0 to 5.0
|
9 participants
Interval 9.0 to 6.0
|
|
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
Thoracic dermatome 6
|
9 participants
|
7 participants
|
8 participants
|
|
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
Thoracic dermatome 7
|
17 participants
|
14 participants
|
16 participants
|
|
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
Thoracic dermatome 8
|
10 participants
|
8 participants
|
6 participants
|
|
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
Thoracic dermatome 9
|
6 participants
|
14 participants
|
10 participants
|
|
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
Sensory level not tested
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 hours following labor analgesiaPopulation: per protocal
Patient satisfaction with analgesia management during labor and delivery. Scores are 0 to 100 with 0 complete dissatisfaction and 100 complete satisfaction with labor analgesia.
Outcome measures
| Measure |
2.5 mL Bolused Every 15 Minutes
n=66 Participants
Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
|
5ml Bolused Every 30 Minutes
n=60 Participants
Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
10ml Bolused Every 60 Minutes
n=54 Participants
Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
|
|---|---|---|---|
|
Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.
|
90 Scores on a scale (0 toi 100)
Interval 78.0 to 99.0
|
94 Scores on a scale (0 toi 100)
Interval 80.0 to 100.0
|
93 Scores on a scale (0 toi 100)
Interval 92.0 to 98.0
|
Adverse Events
2.5 mL Bolused Every 15 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5ml Bolused Every 30 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10ml Bolused Every 60 Minutes
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
Robert J. McCarthy, PharmD
Northwestern University Feinberg School of Medicine
Phone: 312-926-9015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place