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Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses

Effect of Epidural Infusion Bolus Delivery Rate on the Duration of Labor Analgesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02340806
Enrollment
220
Registered
2015-01-19
Start date
2015-01-31
Completion date
2017-03-31
Last updated
2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain, Obstetric Pain

Keywords

epidural bolus, pain management, labor analgesia

Brief summary

Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \[PCEA\]). The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that timed-intermittent boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior maintenance of labor analgesia than maintenance with a continuous infusion with PCEA. Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA recently became commercially available. Several infusion rates are available for delivering the timed bolus, and the optimal bolus rate is unknown.

Detailed description

Cervical dilation will be confirmed by a member of the obstetric team prior to epidural catheter placement as is routinely done at our institution. A baseline pain visual analog scale (VAS) score will be obtained using a 100-mm unmarked line with the end points labeled no pain and worst pain imaginable. Labor analgesia will be initiated using CSE analgesia with 25 mcg of intrathecal fentanyl. An epidural test dose will be performed as routine (1.5% lidocaine with epinephrine 1:200, 3 mL). Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump (Smiths Medical). An unblinded anesthesia research nurse will program the epidural pump and initiate the maintenance of labor analgesia. Fifteen minutes following the intrathecal dose, a VAS score and a sensory level of analgesia will be obtained. The following information will be obtained hourly until complete cervical dilation (10 cm): VAS pain score, sensory level, a modified Bromage score (0 - no motor paralysis; 1 - inability to raise extended leg, but able to move knee and foot; 2 - inability to raise extended leg and to move knee, but able to move foot; 3 - inability to raise extended leg or to move knee and foot). The time to the first request for supplemental analgesia will be recorded on the study data sheet. The time, type and volume of local anesthetic used, and VAS scores before and 15 minutes after the redose will be recorded. All other clinical management will be as per routine, and study participation will not interfere with anesthetic or obstetric care. Anesthesiologists will manage breakthrough pain in the usual manner (assessment of stage of labor and extend/density of neuraxial blockade, followed by the appropriate maneuver to reestablish adequate analgesia). Following delivery, the patient will be asked to give one final VAS score and her overall satisfaction with labor using a 100 mm unmarked line. Mode of delivery, as well as the duration of the 1st and 2nd stage of labor will be recorded by study personnel. Patient Controlled Epidural Analgesia (PCEA) pump utilization data will be downloaded from epidural pumps after delivery. This will include the time to first PCEA request, the number of PCEA demands, the number of times that PCEA boluses were delivered, the total amount of local anesthetic consumed.

Interventions

DEVICECADD-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).

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Term, nulliparous, English-speaking patients with singleton vertex pregnancies, who were 18 years or older, who presented to the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital in spontaneous labor or for induction of labor were eligible to participate in the study

Exclusion criteria

History of chronic opioid analgesic use, prior opioid administration during labor, refusal of a vaginal examination prior to initiation of combined spinal-epidural (CSE) analgesia, or the presence of contraindications to neuraxial analgesia, such as coagulopathy or sepsis. Patients with cervical dilation \> 5cm at the request for an epidural analgesia and women that were dilated \> 5cm upon presentation to the labor and delivery unit were not approached for inclusion in the study; patients were excluded from the study after randomization if request for provider-administered supplemental bolus, or delivery, occurred within 90 minutes of intrathecal injection, or if there was a need for epidural catheter replacement during labor.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Experienced Breakthrough Pain.epidural placement to delivery, up to 36 hours.Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.

Secondary

MeasureTime frameDescription
Total Bupivacaine Consumption Per Hour of Labor Analgesiaepidural placement to delivery, up to 36 hours.Total bupivacaine amount (milligrams/hour mg/h) via pump and provider administered supplemental boluses
Total Number of Requested PCEA Bolusesepidural placement to delivery, up to 36 hours.Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered
Total Number of Delivered PCEA Bolusesepidural placement to delivery, up to 36 hours.Total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's delivered.
Ratio of Total Number of PCEA Boluses Requested and Deliveredepidural 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.
Satisfaction Scoresup to 24 hours after deliveryPatients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management.

Other

MeasureTime frameDescription
Mean Pain Scoreepidural 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.
Stage of Labor at Re-dose RequestThrough 2 stages of labor up to 24 hoursThe stage of labor ( first or second) at the time of re-dose request.
Number of Participants With Epidural Re-dosesepidural placement to delivery, up to 36 hours.Total number of patients requiring epidural re-doses given by the provider.
Patient Satisfaction of Labor AnesthesiaUp 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.
Time to Provider Administered Supplemental Bolusesepidural to first request of redose up to 10 hoursTime to provider administered supplemental boluses measured in minutes

Countries

United States

Participant flow

Recruitment details

220 patients met inclusion criteria.

Participants by arm

ArmCount
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).
102
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).
108
Total210

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyepidural catheter replaced21
Overall Studyhistory of chronic pain medication10
Overall StudyProtocol Violation20
Overall Studyre-dose < 90 min of CSE13

Baseline characteristics

CharacteristicHigh Rate Bolus (CADD-Solis Pump)Low Rate Bolus (CADD-Solis Pump)Total
Age, Continuous32 years31 years31 years
Body Mass Index (kg/m2)29 (kg/m2)29 (kg/m2)29 (kg/m2)
Cervical dilation at request for epidural (cm)2 centimeters2 centimeters2 centimeters
Gestational Age (weeks)40 Weeks40 Weeks40 Weeks
Indication for Cesarean delivery
Arrest of descent
8 Participants5 Participants13 Participants
Indication for Cesarean delivery
Arrest of dilation
7 Participants14 Participants21 Participants
Indication for Cesarean delivery
Fetal Intolerance
9 Participants5 Participants14 Participants
Labor Type
Induction of Labor
71 Participants73 Participants144 Participants
Labor Type
Spontaneous Labor
31 Participants35 Participants66 Participants
Mode of delivery
Assisted Vaginal Delivery
9 Participants13 Participants22 Participants
Mode of delivery
Cesarean Delivery
24 Participants24 Participants48 Participants
Mode of delivery
Vaginal Delivery
69 Participants71 Participants140 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants9 Participants14 Participants
Race (NIH/OMB)
Black or African American
5 Participants7 Participants12 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants13 Participants19 Participants
Race (NIH/OMB)
White
86 Participants79 Participants165 Participants
Sex: Female, Male
Female
102 Participants108 Participants210 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
VAS (visual analog scale)75 units on a scale73 units on a scale74 units on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1020 / 108
other
Total, other adverse events
0 / 1020 / 108
serious
Total, serious adverse events
0 / 1020 / 108

Outcome results

Primary

Number of Participants Who Experienced Breakthrough Pain.

Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.

Time frame: epidural placement to delivery, up to 36 hours.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Rate Bolus (CADD-Solis Pump)Number of Participants Who Experienced Breakthrough Pain.37 Participants
Low Rate Bolus (CADD-Solis Pump)Number of Participants Who Experienced Breakthrough Pain.43 Participants
p-value: 0.67Chi-squared, Corrected
Secondary

Ratio of Total Number of PCEA Boluses Requested and Delivered

The ratio of the total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's requested and PCEA doses delivered.

Time frame: epidural placement to delivery, up to 36 hours.

ArmMeasureValue (MEDIAN)
High Rate Bolus (CADD-Solis Pump)Ratio of Total Number of PCEA Boluses Requested and Delivered1.4 Ratio
Low Rate Bolus (CADD-Solis Pump)Ratio of Total Number of PCEA Boluses Requested and Delivered1.5 Ratio
p-value: 0.66Kruskal-Wallis
Secondary

Satisfaction Scores

Patients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management.

Time frame: up to 24 hours after delivery

ArmMeasureValue (MEDIAN)
High Rate Bolus (CADD-Solis Pump)Satisfaction Scores98 score on a scale (0 poor 100 good)
Low Rate Bolus (CADD-Solis Pump)Satisfaction Scores98 score on a scale (0 poor 100 good)
Secondary

Total Bupivacaine Consumption Per Hour of Labor Analgesia

Total bupivacaine amount (milligrams/hour mg/h) via pump and provider administered supplemental boluses

Time frame: epidural placement to delivery, up to 36 hours.

ArmMeasureValue (MEDIAN)
High Rate Bolus (CADD-Solis Pump)Total Bupivacaine Consumption Per Hour of Labor Analgesia9.9 milligrams per hour
Low Rate Bolus (CADD-Solis Pump)Total Bupivacaine Consumption Per Hour of Labor Analgesia10.8 milligrams per hour
p-value: 0.08Wilcoxon (Mann-Whitney)
Secondary

Total Number of Delivered PCEA Boluses

Total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's delivered.

Time frame: epidural placement to delivery, up to 36 hours.

ArmMeasureValue (MEDIAN)
High Rate Bolus (CADD-Solis Pump)Total Number of Delivered PCEA Boluses9 Doses
Low Rate Bolus (CADD-Solis Pump)Total Number of Delivered PCEA Boluses10 Doses
p-value: 0.14Wilcoxon (Mann-Whitney)
Secondary

Total Number of Requested PCEA Boluses

Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered

Time frame: epidural placement to delivery, up to 36 hours.

ArmMeasureValue (MEDIAN)
High Rate Bolus (CADD-Solis Pump)Total Number of Requested PCEA Boluses14 Doses
Low Rate Bolus (CADD-Solis Pump)Total Number of Requested PCEA Boluses17 Doses
p-value: 0.21Wilcoxon (Mann-Whitney)
Other Pre-specified

Mean Pain Score

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.

Time frame: epidural placement to delivery, up to 36 hours.

ArmMeasureValue (MEAN)
High Rate Bolus (CADD-Solis Pump)Mean Pain Score9 units on a scale
Low Rate Bolus (CADD-Solis Pump)Mean Pain Score6.9 units on a scale
p-value: 0.58Kruskal-Wallis
Other Pre-specified

Number of Participants With Epidural Re-doses

Total number of patients requiring epidural re-doses given by the provider.

Time frame: epidural placement to delivery, up to 36 hours.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
High Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-doses2 re-doses6 Participants
High Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-doses1 re-dose31 Participants
High Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-doses3 re-doses6 Participants
High Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-dosesNo- redoses59 Participants
Low Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-doses3 re-doses5 Participants
Low Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-doses2 re-doses5 Participants
Low Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-dosesNo- redoses71 Participants
Low Rate Bolus (CADD-Solis Pump)Number of Participants With Epidural Re-doses1 re-dose27 Participants
p-value: 0.99Chi-squared
Other Pre-specified

Patient Satisfaction of Labor Anesthesia

Patient satisfaction of labor anesthesia using a score of 0 low satisfaction to 100 high satisfaction on a 100 millimeter scale.

Time frame: Up to 24 hours after delivery of baby

ArmMeasureValue (MEDIAN)
High Rate Bolus (CADD-Solis Pump)Patient Satisfaction of Labor Anesthesia98 score on a scale (0 poor 100 good)
Low Rate Bolus (CADD-Solis Pump)Patient Satisfaction of Labor Anesthesia98 score on a scale (0 poor 100 good)
p-value: 0.37Kruskal-Wallis
Other Pre-specified

Stage of Labor at Re-dose Request

The stage of labor ( first or second) at the time of re-dose request.

Time frame: Through 2 stages of labor up to 24 hours

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
High Rate Bolus (CADD-Solis Pump)Stage of Labor at Re-dose RequestFirst stage of labor34 Participants
High Rate Bolus (CADD-Solis Pump)Stage of Labor at Re-dose RequestSecond stage of labor3 Participants
Low Rate Bolus (CADD-Solis Pump)Stage of Labor at Re-dose RequestFirst stage of labor40 Participants
Low Rate Bolus (CADD-Solis Pump)Stage of Labor at Re-dose RequestSecond stage of labor3 Participants
p-value: 0.67Chi-squared
Other Pre-specified

Time to Provider Administered Supplemental Boluses

Time to provider administered supplemental boluses measured in minutes

Time frame: epidural to first request of redose up to 10 hours

ArmMeasureValue (MEDIAN)
High Rate Bolus (CADD-Solis Pump)Time to Provider Administered Supplemental Boluses357 Minutes
Low Rate Bolus (CADD-Solis Pump)Time to Provider Administered Supplemental Boluses302 Minutes
p-value: 0.92Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026