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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-05-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly divided into two groups. The first group will receive an intrathecal injection of fentanyl, while the second will receive epidural fentanyl.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Spinal

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

Group Type ACTIVE_COMPARATOR

Spinal analgesia

Intervention Type 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.

Epidural

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

Group Type ACTIVE_COMPARATOR

Epidural Analgesia

Intervention Type 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)

Interventions

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Spinal analgesia

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.

Intervention Type PROCEDURE

Epidural Analgesia

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)

Intervention Type PROCEDURE

Other Intervention Names

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Spinal fentanyl Epidural fentanyl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No