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NCT Number: NCT07187427

Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.

The purpose of this study is to investigate the effect of neuraxial analgesia initiation on the incidence of pruritus in laboring women. Specifically, this study aim to compare intrathecal fentanyl with epidural fentanyl in order to determine whether the epidural route is associated with a lower occurrence and severity of pruritus. By clarifying these differences, the research seek to optimize analgesic strategies during labor while minimizing opioid-related side effects

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Key information

Conditions

Pruritis Behavior Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fentanyl Adverse Reaction Fentanyl Analgesia Fetal Bradycardia During Labor Health Behavior Hypotension Hypotension Drug-Induced Labor Analgesia Male Urogenital Diseases Nausea Nausea and Vomitting Neuraxial Opioid Opioid Analgesic Adverse Reaction Pathological Conditions, Signs and Symptoms Patient Satisfaction Pruritus Satisfaction, Patient Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Term Labour Treatment Adherence and Compliance Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location contact

Valérie Zaphiratos, MD, MSc, FRCPC Anesthesiology

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Vaginal delivery
  • Gestational age ≥ 37 weeks
  • Requesting neuraxial analgesia
  • French or English language

Exclusion criteria

  • ASA score > 3
  • Allergy or contraindication to receiving opioids/local anesthesia (morphine or fentanyl)
  • BMI > 40 kg/m²
  • Hepatic or renal failure,
  • Severe preeclampsia and signs of severity according to the criteria of the American College of Obstetricians and Gynecologists
  • Maternal hemorrhage (placental abruption, hepatic subcapsular hematoma,...)
  • Severe scoliosis
  • Biliary cholestasis or polymorphic eruption of pregnancy
  • Inability to provide informed consent, either secondary to mental or physical disability or a significant language barrier (inability to understand English or French)
  • Prior administration of an opioid or opioid misuse

Treatment and study plan

Spinal analgesia

Procedure

All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter.

STEP 1: Intraspinal SPINAL Group: Bupivacaine 0.25% Isobaric 1 ml + Fentanyl 15 mcg, (0,3ml)

STEP 2: Epidural SPINAL group: 0.9% NaCl 2 ml.

Other names: Spinal, fentanyl

Epidural Analgesia

Procedure

All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter.

STEP 1: Intraspinal EPI Group: Bupivacaine 0.25% Isobaric 1 ml + NaCl 0.9% 0.3 ml

STEP 2: Epidural EPI group: Fentanyl 100 mcg, (2 ml of a concentration of 50 mcg/ml)

Other names: Epidural, fentanyl

Primary outcomes

  1. Pruritus

    Time frame: Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia

    Incidence et severity

    • 4-point Likert scale: Absent, light, moderate, severe/unbearable.
    • number of patients treated by antipruritic (Naloxone)

Secondary outcomes

  1. Nausea Vomiting

    Time frame: 2 hours until neuraxial analgesia

    Incidence : Present or not Severity : number of patients treated (antinausea)

  2. Hypotension

    Time frame: 2 hours until neuraxial analgesia

    Incidence : Decrease of arterial systolic pressure < 20% from basal Severity : Total dose of IV ephedrine

  3. Urinary rentention

    Time frame: 24 hours until the neuraxial analgesia

    Number of urinary catheterizations

  4. Maternal satisfaction

    Time frame: 24 hours until neuraxial analgesia

    Maternal satisfaction with neuraxial analgesia using :

    • Quality of Recovery-15 scale (QoR 15) : Score of 150 points to evaluate the recovery. The higher the score, the better the recovery.
    • Overall Benefit of Analgesia Score (OBAS) : multi-dimensional survey that assesses analgesia benefits, opioid-related adverse events, and patient satisfaction. Score of 28. The lowest the score, the better the benefits.

  5. Fetal Bradycardia

    Time frame: 2 hours until neuraxial analgesia

    Incidence of fetal bradycardia Fetal monitoring is performed before and after the procedure. If a non-reassuring tracing is described by the obstetrical team, it will be noted in the patient's file. Fetal rhythm abnormalities via cardiotocogram are defined by nurses or obstetricians.

Study contacts

Contact information is provided by the study sponsor or research team.

Aymen Messadaa, MD, Anesthesiology

CONTACT

[email protected]

514-603-5177

Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology

CONTACT

[email protected]

5146684778

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

Randomized Trial Comparing the Injection of Intrathecal Fentanyl Versus Epidural Fentanyl for the Initiation of Labour Analgesia on the Incidence of Pruritis.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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