Trial Outcomes & Findings for Drug Concentration and Volume on Adequate Labor Analgesia With PIEB (NCT NCT03553576)
NCT ID: NCT03553576
Last Updated: 2025-05-21
Results Overview
Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
146 participants
Primary outcome timeframe
72 hours
Results posted on
2025-05-21
Participant Flow
Subjects were recruited within Prentice Women's Hospital labor and delivery unit. Recruitment period start date was 1/21/2020 and the end date for recruitment was 09/01/2022.
146 subjects consented to participate in the study.
Participant milestones
| Measure |
Low Volume Bolus 0.1% Bupivacaine
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
73
|
|
Overall Study
COMPLETED
|
67
|
62
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
| Measure |
Low Volume Bolus 0.1% Bupivacaine
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Overall Study
MD withdrew (pump settings changed d/t interscapular pain)
|
1
|
1
|
|
Overall Study
Unintentional dural puncture during epidural procedure
|
0
|
1
|
|
Overall Study
No cerebral spinal fluid obtained during epidural procedure a straight catheter was used
|
0
|
1
|
|
Overall Study
Fentanyl and or clonidine administered via epidural catheter
|
1
|
2
|
|
Overall Study
First redose of anesthetic by anesthesiologist administered under 90 minutes after catheter placed
|
1
|
1
|
|
Overall Study
Greater than 3 redoses of anesthetic by the anesthesiologist using the epidural catheter
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
5
|
Baseline Characteristics
Drug Concentration and Volume on Adequate Labor Analgesia With PIEB
Baseline characteristics by cohort
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
32.6 Years
n=5 Participants
|
32.9 Years
n=7 Participants
|
32.8 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
62 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Gestational age
|
39.3 Weeks
n=5 Participants
|
39.6 Weeks
n=7 Participants
|
39.4 Weeks
n=5 Participants
|
|
BMI kg/m^2
|
29.8 kg/m^2
n=5 Participants
|
32.0 kg/m^2
n=7 Participants
|
31 kg/m^2
n=5 Participants
|
|
Number of times pregnant
1 time pregnant
|
44 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Number of times pregnant
2 times pregnant
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Number of times pregnant
3 times pregnant or greater
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Labor type
Spontaneous labor
|
39 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Labor type
Induction of labor
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Fetal position
Vertex position
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Fetal position
Non-vertex position
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cervical dilation at labor analgesia request (cm)
|
3 Centimeters
n=5 Participants
|
4 Centimeters
n=7 Participants
|
3 Centimeters
n=5 Participants
|
|
VAS scores (0 to 100) at labor analgesia request
|
70 units on a scale (0 low (good)-100 high)
n=5 Participants
|
70 units on a scale (0 low (good)-100 high)
n=7 Participants
|
70 units on a scale (0 low (good)-100 high)
n=5 Participants
|
PRIMARY outcome
Timeframe: 72 hoursAnesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Anesthesia Provider Administered Bolus
|
23 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 24 hoursVAS (visual analogue scale) at 10 centimeters dilation of cervix on a scale of 0 (no pain,good) to 100 (worst pain imaginable,bad)
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
VAS at 10 Centimeters Dilation of Cervix
|
1 score on a scale 0 good 100 worst
Interval 0.0 to 22.0
|
9 score on a scale 0 good 100 worst
Interval 0.0 to 36.0
|
SECONDARY outcome
Timeframe: 24 hoursVAS score (Visual Analogue Scale) on a score of 0 (no pain,good) to 100 (worst pain imaginable,bad) immediately after delivery of baby
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
VAS Score After Delivery
|
0 score on a scale 0 good-100 bad
Interval 0.0 to 6.0
|
0 score on a scale 0 good-100 bad
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 72 hoursNumber of participants who experienced intrascapular pain (pain in your shoulder blade) during the study period.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Intrascapular Pain
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 72 hoursNumber of participants requiring anesthesia provider administration of additional bolus doses of pain medication.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Provider Administered Bolus
|
23 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 72 hoursAdditional number of participants who required additional anesthesia care provider redoses of pain medication.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Number of Participants Who Required Additional Provider Redoses
0 Redoses
|
44 Participants
|
51 Participants
|
|
Number of Participants Who Required Additional Provider Redoses
1 Redose
|
9 Participants
|
7 Participants
|
|
Number of Participants Who Required Additional Provider Redoses
2 Redoses
|
8 Participants
|
3 Participants
|
|
Number of Participants Who Required Additional Provider Redoses
3 Redoses
|
5 Participants
|
1 Participants
|
|
Number of Participants Who Required Additional Provider Redoses
4 Redoses
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 72 hoursTime elapsed in minutes from epidural set up to time to request supplemental analgesia provided by the anesthesiology care provider.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Time to First Anesthesiology Provider Bolus
|
270 Minutes
Interval 193.0 to 475.0
|
489 Minutes
Interval 286.0 to 627.0
|
SECONDARY outcome
Timeframe: 72 hoursPatient reported visual analogue scale score (0 no pain,good-100 worst pain imaginable, bad) prior to the first anesthesiology care provider bolus dose of anesthetic (pain medication).
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
VAS Score Prior to First Provider Bolus Dose
|
72 score on a scale 0 good-100 bad
Interval 50.0 to 82.0
|
61 score on a scale 0 good-100 bad
Interval 42.0 to 88.0
|
SECONDARY outcome
Timeframe: 72 hoursPatient reported visual analogue scale score (0 no pain, good -100 worst pain imaginable, bad) 30 minutes after the first anesthesiology care provider bolus dose of anesthetic was administered to the participant for pain relief.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
VAS Score 30 Minutes After Anesthetic Care Provider Dose
|
25 score on a scale 0 good-100 bad
Interval 0.0 to 50.0
|
5 score on a scale 0 good-100 bad
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: 72 hoursAverage consumption of bupivacaine in milligrams per hour.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Bupivacaine Consumption Per Hour
|
13.1 milligrams/hour
Standard Deviation 4
|
11.7 milligrams/hour
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 72 hoursMaximum oxytocin dose administered intravenously in international units.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Maximum Oxytocin Dose
|
12 International Units
Interval 10.0 to 18.0
|
16 International Units
Interval 10.0 to 24.0
|
SECONDARY outcome
Timeframe: 72 hoursElapsed time in minutes from the intrathecal administration of anesthetic by anesthesiology provider to time of delivery of baby.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Time of Intrathecal Administration to Delivery
|
468 Minutes
Interval 330.0 to 736.0
|
575 Minutes
Interval 275.0 to 805.0
|
SECONDARY outcome
Timeframe: 72 hoursMode of delivery identified as: normal vaginal delivery, instrumental vaginal delivery, cesarean delivery or emergency cesarean delivery
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Number of Participants Categorized by Mode of Delivery
Cesarean Delivery
|
15 Participants
|
16 Participants
|
|
Number of Participants Categorized by Mode of Delivery
Vaginal Delivery
|
45 Participants
|
42 Participants
|
|
Number of Participants Categorized by Mode of Delivery
Instrumental Delivery
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 72 hoursNumber of Patient-Controlled Epidural Analgesia (PCEA) boluses of pain medication requested and number of PCEA medication boluses administered.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
PCA Boluses
Boluses Requested
|
7 Boluses
Interval 4.0 to 13.0
|
8 Boluses
Interval 5.0 to 19.0
|
|
PCA Boluses
Boluses Delivered
|
5 Boluses
Interval 3.0 to 9.0
|
5 Boluses
Interval 2.0 to 12.0
|
SECONDARY outcome
Timeframe: 72 hoursThe ratio of the number of Patient-Controlled Epidural Analgesia (PCEA) pain medication boluses requested and number of PCEA pain medication boluses administered by the PCEA pump.
Outcome measures
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 Participants
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 Participants
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
PCA Boluses Ratio
|
1.5 Ratio of requested to delivered boluses
Interval 1.0 to 1.7
|
1.3 Ratio of requested to delivered boluses
Interval 1.1 to 2.0
|
Adverse Events
Low Volume Bolus 0.1% Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Volume Bolus .0625% Bupivacaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Volume Bolus 0.1% Bupivacaine
n=67 participants at risk
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
High Volume Bolus .0625% Bupivacaine
n=62 participants at risk
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
|
|---|---|---|
|
Nervous system disorders
Intrascapular Pain
|
0.00%
0/67 • 72 hours after epidural catheter placement.
Intrascapular pain
|
4.8%
3/62 • Number of events 3 • 72 hours after epidural catheter placement.
Intrascapular pain
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place