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

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ClinicalTrials.gov Identifier: NCT04011098
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Harry Neveling, University of Saskatchewan

Brief 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.


Condition or disease Intervention/treatment Phase
Epidural Labor Pain Induction of Labor Affected Fetus / Newborn Obstetric Anesthesia Problems Obstetric Pain Opioid Drug: Epidural Fentanyl Bolus Drug: Standard Epidural Group Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized control trial (RCT) utilizing parallel groups
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Participants will be randomized to one of two groups according to a 1:1 allocation with blinding of the intervention accomplished by providing the Anesthesia practitioner with either a 3 ml syringe filled with 2 ml of standard epidural mix (control) or 2 ml of Fentanyl (50 mcg/ml)(intervention):

  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.
Primary Purpose: Treatment
Official Title: Improving Labour Induction Analgesia: a Randomized Control Trial of Single Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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 Name: Control Intervention

Experimental: 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.
Drug: 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).
Other Name: Experimental Intervention




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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).

  3. 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 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).

  4. 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 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.


  5. 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 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.

  6. 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. ]
    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).

  7. 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 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.

  8. 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 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.

  9. 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 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.

  10. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011098


Contacts
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Contact: Derick WJ Chang, BA, MD 3063719427 derick.chang@usask.ca
Contact: Harry Neveling, MD, FRCPC 3066551183 harry.neveling@sasktel.net

Locations
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Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Derick WJ Chang, BA, MD    3063719427    derick.chang@usask.ca   
Contact: Harry Neveling, MD, FRCPC    3066551183    harry.neveling@saskatel.net   
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Harry Neveling, MD, FRCPC U of S Department of Anesthesiology, Perioperative Medicine and Pain Management

Publications:

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Responsible Party: Harry Neveling, MD, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT04011098     History of Changes
Other Study ID Numbers: Bio 18-73
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harry Neveling, University of Saskatchewan:
Epidural
Opioids
Fentanyl
Labour Induction
Labour Pain
Obstetric Pain
Induction of Labour
Anesthesia
Obstetric Anesthesia
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General