Trial Outcomes & Findings for Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery. (NCT NCT03307174)
NCT ID: NCT03307174
Last Updated: 2020-05-12
Results Overview
Total local anesthetic consumed while epidural in place, recorded on infusion pump
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
In first 24 hours
Results posted on
2020-05-12
Participant Flow
Patients were enrolled between December 2016 to December 2018
Patients were not randomized to study groups if epidurals were not able to be successfully placed. 2 subjects in the CEI group were no included in the analysis due to missing data 1 subject in the PIEB group was not included in the analysis due to missing data
Participant milestones
| Measure |
Continuous Epidural Infusion
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
46
|
53
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
Reasons for withdrawal
| Measure |
Continuous Epidural Infusion
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Overall Study
Unplanned ICU Administrion
|
5
|
3
|
|
Overall Study
Aborted Surgery
|
1
|
2
|
|
Overall Study
Hypotension
|
6
|
0
|
|
Overall Study
Nonfunctional epidural
|
1
|
1
|
|
Overall Study
Planned epidural removal
|
1
|
0
|
|
Overall Study
Intrathecal catheter placement
|
0
|
1
|
Baseline Characteristics
Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
Baseline characteristics by cohort
| Measure |
Continuous Epidural Infusion
n=60 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=60 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 14 • n=99 Participants
|
55 years
STANDARD_DEVIATION 16 • n=107 Participants
|
57 years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latinx
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Home Medication Use
Acetaminophen
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Home Medication Use
NSAIDS
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Home Medication Use
Gabapentinoids
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Home Medication Use
TCA/SNRI
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Daily opioid consumption
|
0 MME
n=99 Participants
|
0 MME
n=107 Participants
|
0 MME
n=206 Participants
|
|
Pain Severity
Current Pain
|
0 units on a scale
n=99 Participants
|
0 units on a scale
n=107 Participants
|
0 units on a scale
n=206 Participants
|
|
Pain Severity
Worst Pain
|
2 units on a scale
n=99 Participants
|
4 units on a scale
n=107 Participants
|
3 units on a scale
n=206 Participants
|
|
Pain Severity
Least Pain
|
0 units on a scale
n=99 Participants
|
0 units on a scale
n=107 Participants
|
0 units on a scale
n=206 Participants
|
|
Pain Severity
Average Pain
|
1 units on a scale
n=99 Participants
|
2 units on a scale
n=107 Participants
|
1 units on a scale
n=206 Participants
|
|
Average Pain Interference
|
1 units on a scale
n=99 Participants
|
2 units on a scale
n=107 Participants
|
1 units on a scale
n=206 Participants
|
|
World Health Organization Disability Assessment Schedule 2.0
|
12 units on a scale
n=99 Participants
|
19 units on a scale
n=107 Participants
|
17 units on a scale
n=206 Participants
|
|
HADS Anxiety Score
None
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
HADS Anxiety Score
Mild
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
HADS Anxiety Score
Moderate
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
HADS Anxiety Score
Severe
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Depression HADS Score
None
|
50 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Depression HADS Score
Mild
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Depression HADS Score
Moderate
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Depression HADS Score
Severe
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Length of Epidural Therapy
|
2 Days
n=99 Participants
|
2 Days
n=107 Participants
|
2 Days
n=206 Participants
|
|
Type of Surgery
Upper GI (gastric, small intestine)
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Type of Surgery
Lower GI (colorectal)
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Type of Surgery
Hepatobiliary
|
13 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Type of Surgery
Gynecologic
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Intraoperative Opioids
|
38 MME
n=99 Participants
|
44 MME
n=107 Participants
|
39 MME
n=206 Participants
|
PRIMARY outcome
Timeframe: In first 24 hoursPopulation: Note that 2 patients in the CEI group and 1 patient in the PIEB group was not included in the analysis due to missing data.
Total local anesthetic consumed while epidural in place, recorded on infusion pump
Outcome measures
| Measure |
Continuous Epidural Infusion
n=44 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Total Local Anesthetic Utilized in First 24 Hours
|
126 mg
Interval 120.0 to 134.0
|
123 mg
Interval 115.0 to 136.0
|
SECONDARY outcome
Timeframe: While epidural in place (up to 72 hours post operatively)Total opioid consumed (intravenous or po) while epidural in place
Outcome measures
| Measure |
Continuous Epidural Infusion
n=44 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Total Opioid Consumed
24 hours postoperatively
|
12 MME
Interval 0.0 to 28.0
|
16 MME
Interval 0.0 to 27.0
|
|
Total Opioid Consumed
24 - 48 hours postoperatively
|
0 MME
Interval 0.0 to 25.0
|
0 MME
Interval 0.0 to 30.0
|
|
Total Opioid Consumed
48 - 72 hrs postoperatively
|
0 MME
Interval 0.0 to 21.0
|
1 MME
Interval 0.0 to 18.0
|
SECONDARY outcome
Timeframe: While epidural in place (up to 72 hours postoperatively)Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.
Outcome measures
| Measure |
Continuous Epidural Infusion
n=44 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Patient Satisfaction Score
24 hours postoperatively
|
9 score on a scale
Interval 8.0 to 10.0
|
8 score on a scale
Interval 6.5 to 10.0
|
|
Patient Satisfaction Score
24 - 48 hours postoperatively
|
9 score on a scale
Interval 7.0 to 10.0
|
9 score on a scale
Interval 7.3 to 10.0
|
|
Patient Satisfaction Score
48 - 72 hours postoperatively
|
9 score on a scale
Interval 7.0 to 10.0
|
9 score on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: While epidural in place (up to 72 hours postoperatively)Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.
Outcome measures
| Measure |
Continuous Epidural Infusion
n=44 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Average Pain Severity
24 - 48 hours postoperatively
|
3 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 5.0
|
|
Average Pain Severity
24 hours postoperatively
|
3 units on a scale
Interval 1.0 to 4.0
|
5 units on a scale
Interval 2.0 to 5.0
|
|
Average Pain Severity
48 - 72 hours postoperatively
|
3 units on a scale
Interval 1.0 to 4.0
|
3 units on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: While epidural in place (24 hours postoperatively)Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
Outcome measures
| Measure |
Continuous Epidural Infusion
n=44 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Incidence of Hypotension
|
9 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: While epidural in place (up to 72 hours postoperatively)Minimum is 0, maximum is 10. 10 indicates highest pain severity.
Outcome measures
| Measure |
Continuous Epidural Infusion
n=44 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Worst Reported 24 Hour Pain
24 hours postoperatively
|
5 score on a scale
Interval 2.0 to 7.0
|
8 score on a scale
Interval 4.0 to 9.0
|
|
Worst Reported 24 Hour Pain
24 - 48 hours postoperatively
|
6 score on a scale
Interval 3.0 to 8.0
|
6 score on a scale
Interval 3.0 to 8.0
|
|
Worst Reported 24 Hour Pain
48 - 72 hours postoperativley
|
7 score on a scale
Interval 5.0 to 8.0
|
6 score on a scale
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: While epidural in place (up to 72 hours postoperatively)Minimum is 0, maximum is 10. 10 indicates highest pain interference.
Outcome measures
| Measure |
Continuous Epidural Infusion
n=44 Participants
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 Participants
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Average Pain Interference
24 hours postoperatively
|
2 score on a scale
Interval 0.0 to 4.0
|
3 score on a scale
Interval 1.0 to 5.0
|
|
Average Pain Interference
24 - 48 hours postoperatively
|
1 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 4.0
|
|
Average Pain Interference
48 - 72 hours postoperatively
|
2 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 3.0
|
Adverse Events
Continuous Epidural Infusion
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Programmed Intermittent Epidural Bolus
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Epidural Infusion
n=44 participants at risk
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
Programmed Intermittent Epidural Bolus
n=52 participants at risk
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
20.5%
9/44 • Data collected from day of surgery until removal of epidural, on average epidurals were removed between day 1 and 3. Rare clinical scenarios, epidurals can remain as long as 7 days
|
34.6%
18/52 • Data collected from day of surgery until removal of epidural, on average epidurals were removed between day 1 and 3. Rare clinical scenarios, epidurals can remain as long as 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place