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

St. Justine's Hospital

Status: Not yet enrolling

Conditions: Urinary Retention; Term Labour; Fentanyl Analgesia; Labor Analgesia; Neuraxial Opioid; Fetal Bradycardia During Labor; Opioid Analgesic Adverse Reaction; Fentanyl Adverse Reaction; Hypotension Drug-Induced; Nausea and Vomitting; Satisfaction, Patient; Pruritis

Treatments: Procedure: Spinal analgesia; Procedure: Epidural Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07187427

2026-9304

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Spinal

Active Comparator group

Description:

Intrathecal fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + Fentanyl 15mcg And epidural Nacl 0.9%

Treatment:

Procedure: Spinal analgesia

Epidural

Active Comparator group

Description:

Epidural fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + NaCl 0,9% And epidural fentanyl 100mcg

Treatment:

Procedure: Epidural Analgesia