EpiduralPhase 1NCT04011098
Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
A Phase 1 study testing Epidural Fentanyl Bolus and Standard Epidural Group in people with Epidural and Labor Pain, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural, Labor Pain, Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Epidural Fentanyl Bolus and Standard Epidural Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 2 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy parturients
- Parturients presenting for labour induction for post-term pregnancy (i.e. pregnancy beyond 42 weeks gestational age)
- Parturients who have had an uncomplicated pregnancy
Who cannot join
- Parturients presenting for induction of labour for pre-labour (premature) rupture of membranes
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Labour Induction Analgesia: a Randomized Control Trial of Single Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
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.
Read the detailed 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.
- Conditions
- Epidural, Labor Pain, Induction of Labor Affected Fetus / Newborn, Obstetric Anesthesia Problems, Obstetric Pain, Opioid
- Being tested
- Epidural Fentanyl Bolus, Standard Epidural Group
- Keywords
- Epidural, Opioids, Fentanyl, Labour Induction, Labour Pain, Obstetric Pain, Induction of Labour, Anesthesia, Obstetric Anesthesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Fentanyl BolusDrug
Also called Experimental Intervention
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 GroupDrug
Also called Control Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (No Additional Epidural Fentanyl Bolus) | Active comparator | 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. Receives: Drug: Standard Epidural Group |
| Fentanyl bolus group | Experimental | 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. Receives: Drug: Epidural Fentanyl Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labour analgesia quality: Change in verbal rating pain scale (VRS) after epidural placement
Quality of labour analgesia/pain scores will be assessed by the verbal rating pain scale (VRS) with a minimum score of 0 indicating "No Pain" and a maximum score of 10 indicating "Worst Possible Pain". Higher values closer to 10 indicate worse pain/poor analgesia. A score of 2 is indicative of "mild pain", a score of 4 is indicative of "moderate pain", a score of 6 is indicated of "severe pain", and a score of 8 is indicative of "very severe pain".
Verbal rating pain scale will be assessed 1) Prior to epidural placement, 2) 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement.
Measured: Verbal rating pain scale will be assessed 1) Prior to epidural placement, 2) 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Secondary outcomes (10)
Total epidural opioid consumption
Total opioid consumption will be measured by reviewing the epidural pump and adding together the total opioid infused and number PCEA or documented epidural "top-ups" or boluses.
Measured: Total epidural opioid consumption will be summed following fetal delivery and discontinuation of the epidural infusion. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Incidence of failed/incomplete epidurals
Patient charts will be reviewed to look for any signs of a failed or incomplete/inadequate epidural (i.e. need to re-do epidural, concerns regarding incomplete block, need for multiple top-ups).
Measured: Incidence of failed/incomplete epidurals will be determined following fetal delivery and once all chart documents are available for review. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Presence or Absence of Fetal Heart Tracing Abnormalities
Neonatal well-being will be assessed by monitoring for concerns charted about Fetal Heart Tracings. Specifically, patient charts will be reviewed to assess for concerns regarding early decelerations, late decelerations, and variable decelerations. The amount of decelerations will also be documented (if applicable).
Measured: Fetal Heart Tracing abnormalities will be assessed and summed following fetal delivery and once chart documents/fetal heart tracing strips are all available. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Apgar scores
Neonatal well-being will be assessed by recording Apgar scores at 1 minute following fetal delivery, and at 5 minutes following fetal delivery. The maximum and most reassuring Apgar score is 10 which indicates a neonate that is active, has a heart rate over 100 beats per minute, has a prompt response to stimulation, appears pink/well oxygenated and has a vigorous cry. In general, Apgar scores of 7 or higher are typically considered normal for a neonate and neonates with scores above 7 are unlikely to require resuscitative intervention.
Any Apgar score below 7 is abnormal and should alert the care team of the possible need for resuscitative intervention. A score of 4-6 is below normal and means the neonate will likely need medical intervention or resuscitation. Apgar scores of 1-3 are critically low and indicative of a need for resuscitative intervention and intensive care.
Measured: Apgar scores will be recorded at 1 minute following fetal delivery and at 5 minutes following fetal delivery. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Umbilical artery pH value
Neonatal well-being will be assessed by recording and documenting the umbilical artery vein pH lab value drawn at the time of fetal delivery/birth. A umbilical artery pH value < 7.0 will be considered as abnormal and indicative of pathologic fetal acidemia.
Measured: Neonatal well-being will be assessed by recording the umbilical artery pH lab value at the time of fetal delivery/birth. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Breast-feeding quality
Neonatal well-being will be assessed by reviewing postpartum patient charts to look for any documented consults to breastfeeding consultant (i.e. "yes" or "no" regarding the need for breastfeeding consultant). The number of breastfeeding consults will also be documented (if applicable).
Measured: Neonatal breast-feeding quality will assessed and documented following fetal delivery and once all chart documents are available for review. The aim will be to collect this data within 48 hours of fetal delivery via chart review.
Maternal well-being: Respiratory Rate
Maternal well-being will be assessed by recording and documenting the maternal respiratory rate at specific intervals (see Time Frame below). A respiratory rate less than 12 will be considered as abnormal and bradypneic. A respiratory rate greater than 25 will be considered as abnormal and tachypneic.
Measured: Maternal respiratory rate will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Maternal well-being: Heart Rate
Maternal well-being will be assessed by recording and documenting the maternal heart rate at specific intervals (see Time Frame below). A heart rate less than 60 beats per minute will be considered as abnormal and bradycardic. A heart rate greater than 110 beats per minute will be considered as abnormal and tachycardic.
Measured: Maternal heart rate will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Maternal well-being: Blood pressure
Maternal well-being will be assessed by recording and documenting the maternal blood pressure at specific intervals (see Time Frame below). Both systolic and diastolic blood pressures will be recorded. A systolic blood pressure less than 95 mmHg or a diastolic blood pressure less than 55 mmHg will be considered as abnormal and hypotensive. A systolic blood pressure greater than 140 mmHg or a diastolic blood pressure greater than 95 mmHg will be considered as abnormal and hypertensive.
Measured: Maternal blood pressure will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Maternal well-being: Oxygen Saturation (SpO2)
Maternal well-being will be assessed by recording and documenting the maternal oxygen saturation at specific intervals (see Time Frame below). A maternal oxygen saturation less than 94% will be considered as abnormal and indicative of hypoxia.
Measured: Maternal oxygen saturation will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Jul 2019
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: Unable to meet recruitment numbers, lack of participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for EpiduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized control trial (RCT) utilizing parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harry Neveling, University of Saskatchewan
- Investigators
- Harry Neveling, MD, FRCPC, Principal investigator, U of S Department of Anesthesiology, Perioperative Medicine and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011098
- Sponsor's protocol ID
- Bio 18-73
- Status last verified
- Nov 2020
- First submitted
- 6 Jun 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12011870Simkin 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.
PubMed 15544978Melzack 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.
PubMed 6384895Poma 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.
PubMed 27406914Rayburn WF. Minimizing the risks from elective induction of labor. J Reprod Med. 2007 Aug;52(8):671-6.
PubMed 17879826Jones 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.
PubMed 22419342Wang 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.
PubMed 25011701Anim-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.
PubMed 22161362Russell 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.
PubMed 10895741Siddik-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.
PubMed 18823470Beilin 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.
PubMed 16306734Nikkola 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.
PubMed 12580236Lee 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.
PubMed 11799502Ruban 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.
PubMed 11094666Kumar 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.
PubMed 12847541
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Labour Induction Analgesia: a Randomized Control Trial of Single Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
- ClinicalTrials.gov ID
- NCT04011098
- Acronym / sponsor ID
- Bio 18-73
- Conditions
- Epidural, Labor Pain, Induction of Labor Affected Fetus / Newborn, Obstetric Anesthesia Problems, Obstetric Pain, Opioid
- Keywords
- Epidural, Opioids, Fentanyl, Labour Induction, Labour Pain, Obstetric Pain, Induction of Labour, Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet recruitment numbers, lack of participation
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective randomized control trial (RCT) utilizing parallel groups
| Arm | Type | Receives |
|---|---|---|
| Control Group (No Additional Epidural Fentanyl Bolus) | Active comparator | Drug: Standard Epidural GroupThe 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. |
| Fentanyl bolus group | Experimental | Drug: Epidural Fentanyl BolusThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy parturients
- Parturients presenting for labour induction for post-term pregnancy (i.e. pregnancy beyond 42 weeks gestational age)
- Parturients who have had an uncomplicated pregnancy
Key exclusion criteria (12 listed)
- Parturients presenting for induction of labour for pre-labour (premature) rupture of membranes
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Fentanyl BolusAlso: Experimental InterventionFentanyl 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). | Drug | Fentanyl bolus group |
| Standard Epidural GroupAlso: Control InterventionThe 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. | Drug | Control Group (No Additional Epidural Fentanyl Bolus) |
Primary outcome
Labour analgesia quality: Change in verbal rating pain scale (VRS) after epidural placement
Time frame: Verbal rating pain scale will be assessed 1) Prior to epidural placement, 2) 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Quality of labour analgesia/pain scores will be assessed by the verbal rating pain scale (VRS) with a minimum score of 0 indicating "No Pain" and a maximum score of 10 indicating "Worst Possible Pain". Higher values closer to 10 indicate worse pain/poor analgesia. A score of 2 is indicative of "mild pain", a score of 4 is indicative of "moderate pain", a score of 6 is indicated of "severe pain", and a score of 8 is indicative of "very severe pain". Verbal rating pain scale will be assessed 1) Prior to epidural placement, 2) 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement.
10 secondary outcomes
Total epidural opioid consumption
Time frame: Total epidural opioid consumption will be summed following fetal delivery and discontinuation of the epidural infusion. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Incidence of failed/incomplete epidurals
Time frame: Incidence of failed/incomplete epidurals will be determined following fetal delivery and once all chart documents are available for review. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Presence or Absence of Fetal Heart Tracing Abnormalities
Time frame: Fetal Heart Tracing abnormalities will be assessed and summed following fetal delivery and once chart documents/fetal heart tracing strips are all available. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Apgar scores
Time frame: Apgar scores will be recorded at 1 minute following fetal delivery and at 5 minutes following fetal delivery. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Umbilical artery pH value
Time frame: Neonatal well-being will be assessed by recording the umbilical artery pH lab value at the time of fetal delivery/birth. The aim will be to collect this data within 24 hours of fetal delivery via chart review.
Neonatal well-being: Breast-feeding quality
Time frame: Neonatal breast-feeding quality will assessed and documented following fetal delivery and once all chart documents are available for review. The aim will be to collect this data within 48 hours of fetal delivery via chart review.
Maternal well-being: Respiratory Rate
Time frame: Maternal respiratory rate will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Maternal well-being: Heart Rate
Time frame: Maternal heart rate will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Maternal well-being: Blood pressure
Time frame: Maternal blood pressure will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Maternal well-being: Oxygen Saturation (SpO2)
Time frame: Maternal oxygen saturation will be assessed 1) Prior to epidural placement, 2) Every 5 minutes after epidural placement until 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement
Results and safety
The study was stopped early (reason given: Unable to meet recruitment numbers, lack of participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 12011870Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
- Background: PubMed 15544978Simkin 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.
- Background: PubMed 6384895Melzack 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.
- Background: PubMed 27406914Poma 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.
- Background: PubMed 17879826Rayburn WF. Minimizing the risks from elective induction of labor. J Reprod Med. 2007 Aug;52(8):671-6.
- Background: PubMed 22419342Jones 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.
- Background: PubMed 25011701Wang 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.
- Background: PubMed 22161362Anim-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.
- Background: PubMed 10895741Russell 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.
- Background: PubMed 18823470Siddik-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.
- Background: PubMed 16306734Beilin 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.
- Background: PubMed 12580236Nikkola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Neveling, MD, FRCPC principal investigator
U of S Department of Anesthesiology, Perioperative Medicine and Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epidural Fentanyl Bolus and Standard Epidural Group in people with Epidural and Labor Pain, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to meet recruitment numbers, lack of participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labour analgesia quality: Change in verbal rating pain scale (VRS) after epidural placement (time frame: Verbal rating pain scale will be assessed 1) Prior to epidural placement, 2) 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011098, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.