Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour

  • STATUS
    Not Recruiting
  • participants needed
    100
  • sponsor
    University of Saskatchewan
Updated on 19 September 2023
analgesics
analgesia
opioid
respiratory distress
epidural analgesia
pain relieving
induction of labor

Summary

Labour pain can be intensified for labour inductions and women undergoing inductions often have earlier and more frequent requests for analgesia. Current evidence suggests that epidural analgesia effectively manages pain in labour, but may give rise to adverse effects for both the mother and neonate. Opioids are often added to epidurals to improve the quality of analgesia. Despite reassuring findings regarding epidural opioids, other investigators have found an association between epidural opioids and neonatal respiratory distress, lower Neurological and Adaptive Capacity scores, and reduced rates of breastfeeding. Given the heightened implications for the mother and neonate in situations requiring induction of labour, the desire for a positive outcome whilst still providing adequate maternal analgesia is paramount.

This study thus aims to investigate whether a preliminary epidural Fentanyl bolus at the initiation of the epidural may help to improve analgesia for women undergoing labour inductions for post-term pregnancy in a safe manner. Importantly, the main rationale of this proposed practice being that by achieving adequate epidural analgesia earlier in the labour induction, this may lead to better pain control overall and less overall requirements for epidural PCEA boluses and epidural "top-ups" as the induction progresses.

Description

The pain felt during labour is influenced by many physiological and psychosocial factors and often requires some form of relief. Pain can be intensified for labour inductions as the body's natural pain-relieving endorphins are not readily released in response to the increasingly strong and painful uterine contractions- leading to earlier and more frequent requests for analgesia. Induced labour has also been reported as being significantly longer than spontaneous labour. Current evidence suggests that epidural, combined spinal epidural and inhaled analgesia effectively manage pain in labour, but may give rise to adverse effects for both the mother and neonate. Despite this, epidural analgesia is considered the gold standard in the treatment of labor pain and has a role in labour inductions. Opioids are often added to epidurals to improve the quality of analgesia because of their faster onset and superior pain relief. When combined with opioids, lower concentrations of local anesthetic are needed. Such combinations provide adequate analgesic effect while allowing the parturient to maintain maximal motor function.

In studies assessing the safety and efficacy of labour analgesia, neonatal outcome is a primary concern and the use of opioids for labour analgesia is controversial because of the potentially negative effects on neonates. Common indicators of poor neonatal outcomes include a lower Apgar score, a lower Neurological and Adaptive Capacity Score (NACS), and a lower umbilical artery or vein pH value.

Fentanyl is the most widely investigated adjuncts to epidural local anesthetics. Various RCTs comparing epidural local anesthetics with and without fentanyl have found no significant differences in neonatal Apgar scores at one and five minutes between the groups. A recent meta-analysis of twenty-one RCTs involving epidural Fentanyl and Sufentanil concluded that there was no difference in the incidence of Apgar scores < 7 at one and five minutes, no significant differences in the NACS at two hours and at 24 hours, and no significant differences were found in umbilical cord artery pH between the epidural opioid and control groups. This meta-analysis concluded that the common doses of Fentanyl (total dose of 100-500 mcg) and Sufentanil (total dose of 7.5-30 mcg) used with an epidural/spinal technique are safe for neonates up to 24 hours after delivery. Despite reassuring findings regarding epidural opioids, other investigators have found an association between epidural opioids and neonatal respiratory distress and the use of epidural fentanyl has been associated with a NACS that failed to improve by 24 hours in one study. Furthermore, the use of epidural opioids was associated with reduced rates of breastfeeding in some observational studies, but evidence is unclear and debated.

Given the heightened implications for the mother and neonate in situations requiring induction of labour, the desire for a positive outcome whilst still providing adequate maternal analgesia is paramount. This study thus aims to investigate whether a preliminary epidural Fentanyl bolus at the initiation of the epidural may help to improve analgesia for women undergoing labour inductions for post-term pregnancy in a safe manner. Importantly, the main rationale of this proposed practice being that by achieving adequate epidural analgesia earlier in the labour induction, this may lead to better pain control overall and less overall requirements for epidural PCEA boluses and epidural "top-ups" as the induction progresses.

Details
Condition Labor Pain, Pain, Post-Surgical Pain, Pain (Pediatric), Pain, Opioid analgesics, Post-Surgical Pain, Epidural, Obstetric Anesthesia Problems, Pain (Pediatric), Induction of Labor Affected Fetus / Newborn, Induction of Labor Affected Fetus / Newborn, Induction of Labor Affected Fetus / Newborn
Treatment Epidural Fentanyl Bolus, Standard Epidural Group
Clinical Study IdentifierNCT04011098
SponsorUniversity of Saskatchewan
Last Modified on19 September 2023

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note