Labor Pain Clinical Trial
Official title:
Improving Labour Induction Analgesia: a Randomized Control Trial of Single Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
Verified date | November 2020 |
Source | University of Saskatchewan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | November 2, 2020 |
Est. primary completion date | November 2, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
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University of Saskatchewan |
Canada,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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 | 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. | 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. | |
Secondary | 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). | 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. | |
Secondary | 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). | 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. | |
Secondary | 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. |
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. | |
Secondary | 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. | 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. | |
Secondary | 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). | 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. | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 |
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