Labor Pain, Obstetric Pain
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total Bupivacaine Consumption Per Hour of Labor Analgesia | epidural 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 Boluses | epidural placement to delivery, up to 36 hours. | Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered |
| Total Number of Delivered PCEA Boluses | epidural 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 Delivered | 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. |
| Satisfaction Scores | up to 24 hours after delivery | Patients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Score | 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. |
| Stage of Labor at Re-dose Request | Through 2 stages of labor up to 24 hours | The stage of labor ( first or second) at the time of re-dose request. |
| Number of Participants With Epidural Re-doses | epidural placement to delivery, up to 36 hours. | Total number of patients requiring epidural re-doses given by the provider. |
| Patient Satisfaction of Labor Anesthesia | Up to 24 hours after delivery of baby | Patient 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 Boluses | epidural to first request of redose up to 10 hours | Time to provider administered supplemental boluses measured in minutes |
Countries
United States
Participant flow
Recruitment details
220 patients met inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | epidural catheter replaced | 2 | 1 |
| Overall Study | history of chronic pain medication | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | re-dose < 90 min of CSE | 1 | 3 |
Baseline characteristics
| Characteristic | High Rate Bolus (CADD-Solis Pump) | Low Rate Bolus (CADD-Solis Pump) | Total |
|---|---|---|---|
| Age, Continuous | 32 years | 31 years | 31 years |
| Body Mass Index (kg/m2) | 29 (kg/m2) | 29 (kg/m2) | 29 (kg/m2) |
| Cervical dilation at request for epidural (cm) | 2 centimeters | 2 centimeters | 2 centimeters |
| Gestational Age (weeks) | 40 Weeks | 40 Weeks | 40 Weeks |
| Indication for Cesarean delivery Arrest of descent | 8 Participants | 5 Participants | 13 Participants |
| Indication for Cesarean delivery Arrest of dilation | 7 Participants | 14 Participants | 21 Participants |
| Indication for Cesarean delivery Fetal Intolerance | 9 Participants | 5 Participants | 14 Participants |
| Labor Type Induction of Labor | 71 Participants | 73 Participants | 144 Participants |
| Labor Type Spontaneous Labor | 31 Participants | 35 Participants | 66 Participants |
| Mode of delivery Assisted Vaginal Delivery | 9 Participants | 13 Participants | 22 Participants |
| Mode of delivery Cesarean Delivery | 24 Participants | 24 Participants | 48 Participants |
| Mode of delivery Vaginal Delivery | 69 Participants | 71 Participants | 140 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 19 Participants |
| Race (NIH/OMB) White | 86 Participants | 79 Participants | 165 Participants |
| Sex: Female, Male Female | 102 Participants | 108 Participants | 210 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| VAS (visual analog scale) | 75 units on a scale | 73 units on a scale | 74 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 108 |
| other Total, other adverse events | 0 / 102 | 0 / 108 |
| serious Total, serious adverse events | 0 / 102 | 0 / 108 |
Outcome results
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.
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Ratio of Total Number of PCEA Boluses Requested and Delivered | 1.4 Ratio |
| Low Rate Bolus (CADD-Solis Pump) | Ratio of Total Number of PCEA Boluses Requested and Delivered | 1.5 Ratio |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Satisfaction Scores | 98 score on a scale (0 poor 100 good) |
| Low Rate Bolus (CADD-Solis Pump) | Satisfaction Scores | 98 score on a scale (0 poor 100 good) |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Total Bupivacaine Consumption Per Hour of Labor Analgesia | 9.9 milligrams per hour |
| Low Rate Bolus (CADD-Solis Pump) | Total Bupivacaine Consumption Per Hour of Labor Analgesia | 10.8 milligrams per hour |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Total Number of Delivered PCEA Boluses | 9 Doses |
| Low Rate Bolus (CADD-Solis Pump) | Total Number of Delivered PCEA Boluses | 10 Doses |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Total Number of Requested PCEA Boluses | 14 Doses |
| Low Rate Bolus (CADD-Solis Pump) | Total Number of Requested PCEA Boluses | 17 Doses |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Mean Pain Score | 9 units on a scale |
| Low Rate Bolus (CADD-Solis Pump) | Mean Pain Score | 6.9 units on a scale |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | 2 re-doses | 6 Participants |
| High Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | 1 re-dose | 31 Participants |
| High Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | 3 re-doses | 6 Participants |
| High Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | No- redoses | 59 Participants |
| Low Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | 3 re-doses | 5 Participants |
| Low Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | 2 re-doses | 5 Participants |
| Low Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | No- redoses | 71 Participants |
| Low Rate Bolus (CADD-Solis Pump) | Number of Participants With Epidural Re-doses | 1 re-dose | 27 Participants |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Patient Satisfaction of Labor Anesthesia | 98 score on a scale (0 poor 100 good) |
| Low Rate Bolus (CADD-Solis Pump) | Patient Satisfaction of Labor Anesthesia | 98 score on a scale (0 poor 100 good) |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Stage of Labor at Re-dose Request | First stage of labor | 34 Participants |
| High Rate Bolus (CADD-Solis Pump) | Stage of Labor at Re-dose Request | Second stage of labor | 3 Participants |
| Low Rate Bolus (CADD-Solis Pump) | Stage of Labor at Re-dose Request | First stage of labor | 40 Participants |
| Low Rate Bolus (CADD-Solis Pump) | Stage of Labor at Re-dose Request | Second stage of labor | 3 Participants |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Rate Bolus (CADD-Solis Pump) | Time to Provider Administered Supplemental Boluses | 357 Minutes |
| Low Rate Bolus (CADD-Solis Pump) | Time to Provider Administered Supplemental Boluses | 302 Minutes |