Association Between Bolus Rate and Duration of Adequate Labor Analgesia
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor Pain; Obstetric Pain
Intervention: CADD-Solis pump (Smiths Medical) (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Cynthia Wong, MD, Principal Investigator, Affiliation: Northwestern University
Overall contact: Paul Fitzgerald, Email: p-fitzgerald2@northwestern.edu
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.
Clinical Details
Official title: Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses for Maintenance of Labor Analgesia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The primary outcome is the proportion of subjects in each group that have breakthrough pain requiring a manual bolus (redose) by the anesthesiologist.
Secondary outcome: Total number of requested and delivered PCEA bolusesTotal bupivacaine consumption per hour of labor analgesia
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Nulliparous parturients who presents to the labor and delivery unit for an induction
of labor or who are in spontaneous labor, and request neuraxial labor analgesia at <4
cm cervical dilation are eligible to participate.
Exclusion Criteria:
- Patients who are not eligible to receive a combined spinal epidural (CSE) technique
with 25 mcg of intrathecal fentanyl, non-English speaking, who experience failed CSE
analgesia, need to have the epidural catheter replaced during labor, or who deliver
within 90 minutes of initiation of labor analgesia will be excluded from the study.
Locations and Contacts
Paul Fitzgerald, Email: p-fitzgerald2@northwestern.edu
Northwestern Memorial Hospital, Chicago, Illinois 60611, United States; Recruiting Cynthia A Wong, MD, Principal Investigator
Additional Information
Related publications: Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25. Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.
Starting date: January 2015
Last updated: August 9, 2015
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