Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
NCT ID: NCT04011098
Last Updated: 2020-11-04
Study Results
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Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2019-07-01
2020-11-02
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
1. Control group: will receive a 2 ml bolus of standard epidural mix solution after epidural placement followed by standard care infusion of epidural local anesthetic/opioids, with a PCEA pump for subsequent analgesia.
2. Fentanyl bolus group: will receive a 2 ml bolus of epidural Fentanyl (50 mcg/ml; therefore a total dose of 100 mcg) after epidural placement, followed by a standard care infusion of epidural local anesthetic/opioids, with a PCEA pump for subsequent analgesia.
Study Groups
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Control Group (No Additional Epidural Fentanyl Bolus)
The Control group will receive a 2 ml bolus of standard epidural mix solution after epidural placement followed by standard care infusion of epidural local anesthetic/opioids, with a PCEA pump for subsequent analgesia.
Standard Epidural Group
The Control group will receive a 2 ml bolus of standard epidural mix solution (0.08% Bupivicaine with 2 mcg/ml Fentanyl) after epidural placement followed by standard care infusion of the same solution, with a PCEA pump for subsequent analgesia.
Fentanyl bolus group
The Fentanyl bolus group will receive a 2 ml bolus of epidural Fentanyl (50 mcg/ml; therefore a total dose of 100 mcg) after epidural placement, followed by a standard care infusion of epidural local anesthetic/opioids, with a PCEA pump for subsequent analgesia.
Epidural Fentanyl Bolus
Fentanyl bolus refers to the provision of a 2 ml bolus of epidural Fentanyl (50 mcg/ml; therefore a total dose of 100 mcg) after epidural placement, followed by a standard care infusion of epidural local anesthetic/opioids, with a PCEA pump for subsequent analgesia (0.08% Bupivicaine with 2 mcg/ml Fentanyl Solution).
Interventions
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Epidural Fentanyl Bolus
Fentanyl bolus refers to the provision of a 2 ml bolus of epidural Fentanyl (50 mcg/ml; therefore a total dose of 100 mcg) after epidural placement, followed by a standard care infusion of epidural local anesthetic/opioids, with a PCEA pump for subsequent analgesia (0.08% Bupivicaine with 2 mcg/ml Fentanyl Solution).
Standard Epidural Group
The Control group will receive a 2 ml bolus of standard epidural mix solution (0.08% Bupivicaine with 2 mcg/ml Fentanyl) after epidural placement followed by standard care infusion of the same solution, with a PCEA pump for subsequent analgesia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parturients presenting for labour induction for post-term pregnancy (i.e. pregnancy beyond 42 weeks gestational age)
* Parturients who have had an uncomplicated pregnancy
Exclusion Criteria
* Parturients presenting for induction of labour for hypertensive disorders of pregnancy \[including preeclampsia, eclampsia, HELLP syndrome (Hemolysis, Elevated Liver enzymes, Low Platelets)\]
* Parturients with maternal diabetes
* Fetal growth restriction
* Multiple gestation pregnancy
* Known or suspected Chorioamnionitis
* Known or suspected Abruptio placentae
* Oligohydramnios
* Parturients with cholestasis of pregnancy
* Known alloimmunization with fetal effects.
* Parturients with other chronic medical conditions or any complications related to pregnancy
* Participants who lack capacity to consent on their own behalf
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Saskatchewan
OTHER
Responsible Party
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Harry Neveling
MD
Principal Investigators
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Harry Neveling, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
U of S Department of Anesthesiology, Perioperative Medicine and Pain Management
Locations
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Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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References
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Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
Simkin P, Bolding A. Update on nonpharmacologic approaches to relieve labor pain and prevent suffering. J Midwifery Womens Health. 2004 Nov-Dec;49(6):489-504. doi: 10.1016/j.jmwh.2004.07.007.
Melzack R. The myth of painless childbirth (the John J. Bonica lecture). Pain. 1984 Aug;19(4):321-337. doi: 10.1016/0304-3959(84)90079-4. No abstract available.
Poma S, Scudeller L, Gardella B, Broglia F, Ciceri M, Fuardo M, Pellicori S, Repossi F, Zizzi S, Noli S, Delmonte MP, Iotti GA. Outcomes of induced versus spontaneous labor. J Matern Fetal Neonatal Med. 2017 May;30(10):1133-1138. doi: 10.1080/14767058.2016.1205028. Epub 2016 Jul 13.
Rayburn WF. Minimizing the risks from elective induction of labor. J Reprod Med. 2007 Aug;52(8):671-6.
Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
Wang K, Cao L, Deng Q, Sun LQ, Gu TY, Song J, Qi DY. The effects of epidural/spinal opioids in labour analgesia on neonatal outcomes: a meta-analysis of randomized controlled trials. Can J Anaesth. 2014 Aug;61(8):695-709. doi: 10.1007/s12630-014-0185-y. Epub 2014 Jul 11.
Anim-Somuah M, Smyth RM, Jones L. Epidural versus non-epidural or no analgesia in labour. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD000331. doi: 10.1002/14651858.CD000331.pub3.
Russell R. The effects of regional analgesia on the progress of labour and delivery. Br J Anaesth. 2000 Jun;84(6):709-12. doi: 10.1093/bja/84.6.709. No abstract available.
Siddik-Sayyid SM, Taha SK, Azar MS, Hakki MA, Yaman RA, Baraka AS, Aouad MT. Comparison of three doses of epidural fentanyl followed by bupivacaine and fentanyl for labor analgesia. Acta Anaesthesiol Scand. 2008 Oct;52(9):1285-90. doi: 10.1111/j.1399-6576.2008.01765.x.
Beilin Y, Bodian CA, Weiser J, Hossain S, Arnold I, Feierman DE, Martin G, Holzman I. Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: a prospective, randomized, double-blind study. Anesthesiology. 2005 Dec;103(6):1211-7. doi: 10.1097/00000542-200512000-00016.
Nikkola EM, Jahnukainen TJ, Ekblad UU, Kero PO, Salonen MA. Neonatal monitoring after maternal fentanyl analgesia in labor. J Clin Monit Comput. 2000;16(8):597-608. doi: 10.1023/a:1012268617009.
Lee BB, Ngan Kee WD, Lau WM, Wong AS. Epidural infusions for labor analgesia: a comparison of 0.2% ropivacaine, 0.1% ropivacaine, and 0.1% ropivacaine with fentanyl. Reg Anesth Pain Med. 2002 Jan-Feb;27(1):31-6. doi: 10.1053/rapm.2002.27836.
Ruban P, Sia AT, Chong JL. The effect of adding fentanyl to ropivacaine 0.125% on patient-controlled epidural analgesia during labour. Anaesth Intensive Care. 2000 Oct;28(5):517-21. doi: 10.1177/0310057X0002800505.
Kumar M, Paes B. Epidural opioid analgesia and neonatal respiratory depression. J Perinatol. 2003 Jul-Aug;23(5):425-7. doi: 10.1038/sj.jp.7210905.
Loftus JR, Hill H, Cohen SE. Placental transfer and neonatal effects of epidural sufentanil and fentanyl administered with bupivacaine during labor. Anesthesiology. 1995 Aug;83(2):300-8. doi: 10.1097/00000542-199508000-00010.
Jordan S, Emery S, Bradshaw C, Watkins A, Friswell W. The impact of intrapartum analgesia on infant feeding. BJOG. 2005 Jul;112(7):927-34. doi: 10.1111/j.1471-0528.2005.00548.x.
Torvaldsen S, Roberts CL, Simpson JM, Thompson JF, Ellwood DA. Intrapartum epidural analgesia and breastfeeding: a prospective cohort study. Int Breastfeed J. 2006 Dec 11;1:24. doi: 10.1186/1746-4358-1-24.
Reynolds F. Labour analgesia and the baby: good news is no news. Int J Obstet Anesth. 2011 Jan;20(1):38-50. doi: 10.1016/j.ijoa.2010.08.004. Epub 2010 Dec 13.
Wilson MJ, MacArthur C, Cooper GM, Bick D, Moore PA, Shennan A; COMET Study Group UK. Epidural analgesia and breastfeeding: a randomised controlled trial of epidural techniques with and without fentanyl and a non-epidural comparison group. Anaesthesia. 2010 Feb;65(2):145-53. doi: 10.1111/j.1365-2044.2009.06136.x. Epub 2009 Nov 12.
Other Identifiers
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Bio 18-73
Identifier Type: -
Identifier Source: org_study_id