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

NCT07187427 | Not Yet Recruiting DMC

• 1 other identifier: 2026-9304
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

neuraxial opioid induced pruritus during labor; Intrathecal fentanyl versus Epidural fentanyl

Outcome Measures

Primary Outcomes (1)

• Pruritus

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

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

Secondary Outcomes (5)

• Nausea Vomiting

  2 hours until neuraxial analgesia

• Hypotension

  2 hours until neuraxial analgesia

• Urinary rentention

  24 hours until the neuraxial analgesia

• Maternal satisfaction

  24 hours until neuraxial analgesia

• Fetal Bradycardia

  2 hours until neuraxial analgesia

Study Arms (2)

Spinal

ACTIVE COMPARATOR

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

Procedure: Spinal analgesia

Epidural

ACTIVE COMPARATOR

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

Procedure: Epidural Analgesia

Interventions

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.

Also known as: Spinal, fentanyl

Spinal

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)

Also known as: Epidural, fentanyl

Epidural

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (6)

• Grangier L, Martinez de Tejada B, Savoldelli GL, Irion O, Haller G. Adverse side effects and route of administration of opioids in combined spinal-epidural analgesia for labour: a meta-analysis of randomised trials. Int J Obstet Anesth. 2020 Feb;41:83-103. doi: 10.1016/j.ijoa.2019.09.004. Epub 2019 Sep 23.

  PMID: 31704251 BACKGROUND

• Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045.

  PMID: 24106351 BACKGROUND

• Wong CA, Scavone BM, Slavenas JP, Vidovich MI, Peaceman AM, Ganchiff JN, Strauss-Hoder T, McCarthy RJ. Efficacy and side effect profile of varying doses of intrathecal fentanyl added to bupivacaine for labor analgesia. Int J Obstet Anesth. 2004 Jan;13(1):19-24. doi: 10.1016/S0959-289X(03)00106-7.

  PMID: 15321435 BACKGROUND

• Shah MK, Sia AT, Chong JL. The effect of the addition of ropivacaine or bupivacaine upon pruritus induced by intrathecal fentanyl in labour. Anaesthesia. 2000 Oct;55(10):1008-13. doi: 10.1046/j.1365-2044.2000.01618-2.x.

  PMID: 11012498 BACKGROUND

• Palmer CM, Cork RC, Hays R, Van Maren G, Alves D. The dose-response relation of intrathecal fentanyl for labor analgesia. Anesthesiology. 1998 Feb;88(2):355-61. doi: 10.1097/00000542-199802000-00014.

  PMID: 9477056 BACKGROUND

• Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.

  PMID: 28067707 BACKGROUND

MeSH Terms

Conditions

Pruritus; Hypotension; Urinary Retention; Nausea; Patient Satisfaction

Interventions

Fentanyl; Analgesia, Epidural; Injections, Epidural

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms, Digestive; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesia; Anesthesia and Analgesia; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology

CONTACT

5146684778; valerie@zaphiratos.ca

Aymen Messadaa, MD, Anesthesiology

CONTACT

514-603-5177; aymen.messadaa@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)