Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417027
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2006-12-27
Brief Title:
Programmed Intermittent Epidural Bolus Time Interval and Injection Volume
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Studies suggest that administration of maintenance epidural solutions as programmed or automated intermittent boluses rather than continuous infusions result in lower bupivacaine consumption decreased need for manual boluses by the anesthesiologist and greater patient satisfaction In this technique the epidural maintenance dose is administered as a bolus by the infusion pump at regular intervals instead of as a continuous infusion However the optimal combination of bolus volume and dosing interval has not been determined At one end of the spectrum a small volume and short bolus dose interval will likely behave like a continuous infusion At the other end of the spectrum a large volume and long bolus dose interval may lead to an increased incidence of breakthrough pain The purpose of this randomized double-blind trial was to determine how manipulation of the programmed intermittent time interval and volume influences total drug use quality of analgesia and patient satisfaction during maintenance of labor analgesia We hypothesized that manipulation of the programmed intermittent bolus time interval and volume during the maintenance of epidural labor analgesia influences total drug use quality of analgesia and patient satisfaction
Detailed Description:
Traditionally neuraxial labor analgesia was maintained for the duration of labor with manual intermittent bolus injection of anesthetic by the anesthesiologist via an in-dwelling epidural catheter During the last decade there has been a transition to maintenance of analgesia with a continuous epidural infusion Analgesia is maintained with fewer episodes of breakthrough pain and parturient satisfaction is increased The anesthesiologists workload is less More recently use of patient controlled epidural analgesia PCEA has become popular usually a continuous infusion is supplemented by patient-activated bolus injections
Studies have compared the intermittent manual epidural bolus technique to continuous infusion continuous infusion to PCEA without a background infusion and PCEA with and without a background infusion Studies vary in the epidural solution local anesthetic mass volume and concentration and lock-out intervals The incidence and intensity of motor blockade is greater with continuous infusion compared to bolus administration of the same concentrationmass local anesthetic per unit time whether the bolus is administered manually or by PCEA Consumption of local anesthetic is less with bolus administration manual or PCEA compared to continuous infusion Therefore lower concentrations of local anesthetic are frequently used for continuous infusions
Current pump technology supports continuous epidural infusion PCEA without a background infusion and PCEA with a background infusion Current pump technology does not support programmed intermittent bolus administration with or without supplemental PCEA Further study in this area may motivate pump manufacturers to redesign their pumps to support this type of drug administration
The purpose of the study is to determine how manipulation of the programmed intermittent time interval and volume influences total drug use quality of analgesia and patient satisfaction during maintenance of labor analgesia
Eligible women were asked to participate shortly after admission to the Labor and Delivery Unit at Prentice Womens Hospital immediately following the routine preanesthetic interview Informed written consent was obtained At the time of request for labor analgesia the cervix was examined and a baseline Visual Analog Scale VAS for pain 100 mm unmarked line with the end points labeled no pain and worst pain imaginable was determined Labor analgesia was initiated with a routine combined spinal epidural CSE technique The VAS for pain was determined 10 minutes after the intrathecal injection If the VAS was less than 10 mm the parturient was randomized by a computer generated random number table to one of three programmed intermittent epidural bolus analgesia maintenance techniques 25 mL every 15 minutes 5 mL every 30 minutes or 10 mL every 60 minutes All epidural solutions consisted of bupivacaine 00625 with fentanyl 195 microgramsmL The initial programmed intermittent bolus dose was initiated 30 minutes after the intrathecal injection in all groups
Programmed intermittent epidural doses were administered via a Hospira Gemstar infusion pump A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist Thus two pumps were prepared for each subject with the same epidural solution One pump was programmed to administer the programmed intermittent boluses at a rate of 300 mlhr at regular intervals The second pump was programmed to administer the patients controlled epidural analgesia
VAS scores for pain were determined every 120 minutes until complete cervical dilation beginning 60 minutes after the intrathecal injection A modified Bromage score was determined every 120 minutes during the 1st stage of labor 0no motor paralysis 1inability to raise extended leg but able to move knee and foot 2inability to raise extended leg and to move knee but able to move foot 3inability to raise extended leg or to move knee and foot Sensory threshold to a rigid von Frye filament pressure applied with the rigid tip until the subject reported feeling pressure at the thoracic dermatome of T12 T10 T7 and T4 was determined bilaterally at initiation of epidural and 3 hours after the intrathecal injection Epidural infusion was discontinued shortly after delivery Prior to discharge from the Labor and Delivery Unit the parturient was asked to mark her overall satisfaction with labor analgesia using a 100 mm unmarked line with the left end labeled not satisfied at all and the right end labeled extremely satisfied
Studies have compared the intermittent manual epidural bolus technique to continuous infusion continuous infusion to PCEA without a background infusion and PCEA with and without a background infusion Studies vary in the epidural solution local anesthetic mass volume and concentration and lock-out intervals The incidence and intensity of motor blockade is greater with continuous infusion compared to bolus administration of the same concentrationmass local anesthetic per unit time whether the bolus is administered manually or by PCEA Consumption of local anesthetic is less with bolus administration manual or PCEA compared to continuous infusion Therefore lower concentrations of local anesthetic are frequently used for continuous infusions
Current pump technology supports continuous epidural infusion PCEA without a background infusion and PCEA with a background infusion Current pump technology does not support programmed intermittent bolus administration with or without supplemental PCEA Further study in this area may motivate pump manufacturers to redesign their pumps to support this type of drug administration
The purpose of the study is to determine how manipulation of the programmed intermittent time interval and volume influences total drug use quality of analgesia and patient satisfaction during maintenance of labor analgesia
Eligible women were asked to participate shortly after admission to the Labor and Delivery Unit at Prentice Womens Hospital immediately following the routine preanesthetic interview Informed written consent was obtained At the time of request for labor analgesia the cervix was examined and a baseline Visual Analog Scale VAS for pain 100 mm unmarked line with the end points labeled no pain and worst pain imaginable was determined Labor analgesia was initiated with a routine combined spinal epidural CSE technique The VAS for pain was determined 10 minutes after the intrathecal injection If the VAS was less than 10 mm the parturient was randomized by a computer generated random number table to one of three programmed intermittent epidural bolus analgesia maintenance techniques 25 mL every 15 minutes 5 mL every 30 minutes or 10 mL every 60 minutes All epidural solutions consisted of bupivacaine 00625 with fentanyl 195 microgramsmL The initial programmed intermittent bolus dose was initiated 30 minutes after the intrathecal injection in all groups
Programmed intermittent epidural doses were administered via a Hospira Gemstar infusion pump A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist Thus two pumps were prepared for each subject with the same epidural solution One pump was programmed to administer the programmed intermittent boluses at a rate of 300 mlhr at regular intervals The second pump was programmed to administer the patients controlled epidural analgesia
VAS scores for pain were determined every 120 minutes until complete cervical dilation beginning 60 minutes after the intrathecal injection A modified Bromage score was determined every 120 minutes during the 1st stage of labor 0no motor paralysis 1inability to raise extended leg but able to move knee and foot 2inability to raise extended leg and to move knee but able to move foot 3inability to raise extended leg or to move knee and foot Sensory threshold to a rigid von Frye filament pressure applied with the rigid tip until the subject reported feeling pressure at the thoracic dermatome of T12 T10 T7 and T4 was determined bilaterally at initiation of epidural and 3 hours after the intrathecal injection Epidural infusion was discontinued shortly after delivery Prior to discharge from the Labor and Delivery Unit the parturient was asked to mark her overall satisfaction with labor analgesia using a 100 mm unmarked line with the left end labeled not satisfied at all and the right end labeled extremely satisfied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None