N/A N=220 Randomized Triple-blind Treatment

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

Labor Pain · Obstetric Pain

Bottom Line

View on ClinicalTrials.gov: NCT02340806 ↗

Enrolled (actual)

220

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Number of Participants Who Experienced Breakthrough Pain. — 37; 43 Participants — p=.67

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CADD-Solis pump (Smiths Medical) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Northwestern University
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experienced Breakthrough Pain.	37; 43	.67
SECONDARY Total Bupivacaine Consumption Per Hour of Labor Analgesia	9.9; 10.8	.08
SECONDARY Total Number of Requested PCEA Boluses	14; 17	.21
SECONDARY Total Number of Delivered PCEA Boluses	9; 10	.14
SECONDARY Ratio of Total Number of PCEA Boluses Requested and Delivered	1.4; 1.5	.66
SECONDARY Satisfaction Scores	98; 98	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02340806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.