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

NCT04011098 | Terminated Phase 1

• 1 other identifier: Bio 18-73
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

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; Obstetric Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Total epidural opioid consumption

  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

  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

  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

  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 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.

Study Arms (2)

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.

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.

Drug: Epidural Fentanyl Bolus

Interventions

Epidural Fentanyl Bolus DRUG

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).

Also known as: Experimental Intervention

Fentanyl bolus group

Standard Epidural Group DRUG

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.

Also known as: Control Intervention

Control Group (No Additional Epidural Fentanyl Bolus)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (20)

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  PMID: 19912160 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry Neveling, MD, FRCPC

  U of S Department of Anesthesiology, Perioperative Medicine and Pain Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective randomized control trial (RCT) utilizing parallel groups

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: July 8, 2019
• Study Start: July 1, 2019
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

CA (1)