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Completed

NCT Number: NCT02340806

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CADD-Solis pump (Smiths Medical)

Device

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).

Primary outcomes

  1. Number of Participants Who Experienced Breakthrough Pain.

    Time frame: 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 outcomes

  1. Total Bupivacaine Consumption Per Hour of Labor Analgesia

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

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

  2. Total Number of Requested PCEA Boluses

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

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

  3. Total Number of Delivered PCEA Boluses

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

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

  4. Ratio of Total Number of PCEA Boluses Requested and Delivered

    Time frame: 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.

  5. Satisfaction Scores

    Time frame: 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 outcomes

  1. Time to Provider Administered Supplemental Boluses

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

    Time to provider administered supplemental boluses measured in minutes

  2. Mean Pain Score

    Time frame: 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.

  3. Stage of Labor at Re-dose Request

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

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

  4. Number of Participants With Epidural Re-doses

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

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

  5. Patient Satisfaction of Labor Anesthesia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2015
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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