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

Completed · Not applicable

Conditions studied: Labor Pain, Obstetric Pain

In brief

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.

Key facts

Study ID

NCT02340806

Run by

Northwestern University

People needed

220

Starts

2015-01-01

Expected to finish

2017-03-01

Last updated by the study team

2019-11-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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