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

Not Applicable

Completed

• Conditions: Obstetric Pain; Labor Pain
• Interventions: Device: CADD-Solis pump (Smiths Medical)

• Registration Number: NCT02340806
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2014-12-29
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-19
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Results First Submitted: 2019-06-19
• Results First Submitted QC: 2019-09-09
• Results First Posted: 2019-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low rate bolus (CADD-Solis pump)	CADD-Solis pump (Smiths Medical)	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.
High rate bolus (CADD-Solis pump)	CADD-Solis pump (Smiths Medical)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
Total Number of Requested PCEA Boluses	epidural placement to delivery, up to 36 hours.	Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States