Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-11-19
Brief Title:
Programmed Intermittent Epidural Bolus PIEB Techniques for Labour Analgesia
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Programmed Intermittent Epidural Bolus PIEB Techniques for Labour Analgesia Finding the Optimum Combination
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
PIEB
Brief Summary:
Epidural Analgesia remains the most effective form of pain relief in labour After initiating epidural analgesia there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter Due to recent advances in medical technology new epidural pumps which allow both patient controlled epidural analgesia boluses PCEA a common standard of care in many hospitals and programmed intermittent epidural boluses PIEB automatic boluses given in addition to the PCEA bolus are now available In this randomized double-blind trial we aim to evaluate the effects of different combinations of PIEB epidural bolus volume and PIEB bolus volume and time interval on labour patient-controlled epidural analgesia PCEA usage In theory the more effective the PIEB combination the ideal drug volume and ideal time interval the less PCEA boluses extra epidural drug will be used as well as less clinician boluses and less lower limb weakness motor block as assessed by the Bromage Score
Detailed Description:
Many women experience severe pain during labour There are many forms of pain relief methods available to women in developed countries Labour epidural analgesia remains the most effective form of pain relief It is also the least depressive to the central nervous system of the mother and the baby After initiating epidural analgesia there are many regimens that can be employed to maintain analgesia for the duration of labour
Traditionally epidural analgesia using low dose mixtures of local anaesthetic and opioid has been administered by nurse or midwife-controlled manual boluses or as continuous infusion via a dedicated epidural pump once the epidural catheter has been placed by an anaesthetist Although these regimens provide an effective form of labour analgesia patient satisfaction is not always achieved because of the associated lower limb motor block leg weakness and the increased risk of requiring instrumental delivery such as a forceps delivery Due to recent advances in medical technology new epidural pumps which allow patient controlled epidural analgesia PCEA boluses and programmed intermittent epidural PIEB boluses are now available
Bolus injection through an epidural catheter may result in better distribution of anaesthetic solution in the epidural space when compared with continuous infusion of the same low dose local anaesthetic opioid mixture Capogna et al carried out a randomized double-blind study to compare the effects of a programmed intermittent epidural bolus PIEB regimen with a continuous epidural infusion CEI Motor block was reported in 37 in the CEI group and in only 27 in the PIEB group P 0001 The incidence of instrumental delivery was 20 for the CEI group and 7 for the PIEB group P 003 The total local anaesthetic consumption number of patients requiring additional PCEA boluses and mean number of PCEA boluses per patient were also found to be lower in the PIEB group P 0001 There were no differences in pain scores and duration of labour analgesia Capogna et al 2011 Another randomized controlled study published by Wong et al compared total local anaesthetic bupivacaine was used in this study consumption need for supplemental epidural analgesia quality of analgesia and patient satisfaction in women who received programmed intermittent epidural boluses PIEB compared with continuous epidural infusion CEI for maintenance of labour epidural analgesia The median total bupivacaine dose per hour of analgesia was significantly less in the PIEB n 63 105 mgh 95 confidence interval 95-118 mgh when compared with the CEI group n 63 123 mgh 95 confidence interval 105-140 mgh P 001 Patient satisfaction scores were also higher in the PIEB group The authors concluded that PIEB combined with patient controlled epidural analgesia PCEA provided similar analgesia but with a smaller bupivacaine dose and better patient satisfaction compared with CEI with PCEA for maintenance of epidural labour analgesia Wong et al 2006 Wong et al carried out another study to evaluate bupivacaine consumption and other analgesic outcomes when the programmed intermittent bolus time interval and volume were manipulated during the maintenance of epidural labour analgesia They found that extending the programmed intermittent bolus interval and volume from 15 minutes to 60 minutes and 25 mL to 10 mL respectively decreased bupivacaine consumption without decreasing patient comfort or satisfaction Wong et al 2011 In our study we aim to compare the effects of different combinations of PIEB bolus volume and PIEB time interval on the number of PCEA demands clinician boluses pain score local anaesthetic consumption and patient satisfaction in order to find the optimal PIEB volume and PIEB time interval for labour pain relief when used together with a fixed pre-determined PCEA regimen
Traditionally epidural analgesia using low dose mixtures of local anaesthetic and opioid has been administered by nurse or midwife-controlled manual boluses or as continuous infusion via a dedicated epidural pump once the epidural catheter has been placed by an anaesthetist Although these regimens provide an effective form of labour analgesia patient satisfaction is not always achieved because of the associated lower limb motor block leg weakness and the increased risk of requiring instrumental delivery such as a forceps delivery Due to recent advances in medical technology new epidural pumps which allow patient controlled epidural analgesia PCEA boluses and programmed intermittent epidural PIEB boluses are now available
Bolus injection through an epidural catheter may result in better distribution of anaesthetic solution in the epidural space when compared with continuous infusion of the same low dose local anaesthetic opioid mixture Capogna et al carried out a randomized double-blind study to compare the effects of a programmed intermittent epidural bolus PIEB regimen with a continuous epidural infusion CEI Motor block was reported in 37 in the CEI group and in only 27 in the PIEB group P 0001 The incidence of instrumental delivery was 20 for the CEI group and 7 for the PIEB group P 003 The total local anaesthetic consumption number of patients requiring additional PCEA boluses and mean number of PCEA boluses per patient were also found to be lower in the PIEB group P 0001 There were no differences in pain scores and duration of labour analgesia Capogna et al 2011 Another randomized controlled study published by Wong et al compared total local anaesthetic bupivacaine was used in this study consumption need for supplemental epidural analgesia quality of analgesia and patient satisfaction in women who received programmed intermittent epidural boluses PIEB compared with continuous epidural infusion CEI for maintenance of labour epidural analgesia The median total bupivacaine dose per hour of analgesia was significantly less in the PIEB n 63 105 mgh 95 confidence interval 95-118 mgh when compared with the CEI group n 63 123 mgh 95 confidence interval 105-140 mgh P 001 Patient satisfaction scores were also higher in the PIEB group The authors concluded that PIEB combined with patient controlled epidural analgesia PCEA provided similar analgesia but with a smaller bupivacaine dose and better patient satisfaction compared with CEI with PCEA for maintenance of epidural labour analgesia Wong et al 2006 Wong et al carried out another study to evaluate bupivacaine consumption and other analgesic outcomes when the programmed intermittent bolus time interval and volume were manipulated during the maintenance of epidural labour analgesia They found that extending the programmed intermittent bolus interval and volume from 15 minutes to 60 minutes and 25 mL to 10 mL respectively decreased bupivacaine consumption without decreasing patient comfort or satisfaction Wong et al 2011 In our study we aim to compare the effects of different combinations of PIEB bolus volume and PIEB time interval on the number of PCEA demands clinician boluses pain score local anaesthetic consumption and patient satisfaction in order to find the optimal PIEB volume and PIEB time interval for labour pain relief when used together with a fixed pre-determined PCEA regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None