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PruritisNCT07187427

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

A study testing Spinal analgesia and Epidural Analgesia in people with Pruritis and Hypotension Drug-Induced, run by St. Justine's Hospital at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Spinal analgesia and Epidural Analgesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
Jan 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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,...)
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology contact

5146684778

valerie@zaphiratos.ca

Aymen Messadaa, MD, Anesthesiology contact

514-603-5177

aymen.messadaa@umontreal.ca

Canada1 site

  • Centre Hospitalier Universitaire de Sainte Justine

    Montreal, Quebec, H3T 1C5

    Valérie Zaphiratos, MD, MSc, FRCPC Anesthesiology

Other trials in Canada

About this study

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

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

Being tested
Spinal analgesia, Epidural Analgesia
Keywords
neuraxial opioid induced pruritus during labor, Intrathecal fentanyl versus Epidural fentanyl
Medical subject headings
Pruritus, Hypotension, Urinary Retention, Nausea, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal analgesiaProcedure or surgery

    Also called Spinal, fentanyl

    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 AnalgesiaProcedure or surgery

    Also called Epidural, fentanyl

    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)

Study groups in NCT07187427
Study groupRoleWhat they receive
SpinalActive comparatorIntrathecal fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + Fentanyl 15mcg And epidural Nacl 0.9%
Receives: Procedure: Spinal analgesia
EpiduralActive comparatorEpidural fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + NaCl 0,9% And epidural fentanyl 100mcg
Receives: Procedure: Epidural Analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pruritus

    Incidence et severity

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

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

Secondary outcomes (5)

  1. Nausea Vomiting

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

    Measured: 2 hours until neuraxial analgesia

  2. Hypotension

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

    Measured: 2 hours until neuraxial analgesia

  3. Urinary rentention

    Number of urinary catheterizations

    Measured: 24 hours until the neuraxial analgesia

  4. Maternal satisfaction

    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.

    Measured: 24 hours until neuraxial analgesia

  5. Fetal Bradycardia

    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.

    Measured: 2 hours until neuraxial analgesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187427
Sponsor's protocol ID
2026-9304
Status last verified
Nov 2025
First submitted
18 Sep 2025
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31704251

  • 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.

    PubMed 24106351

  • 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.

    PubMed 15321435

  • 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.

    PubMed 11012498

  • 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.

    PubMed 9477056

  • 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.

    PubMed 28067707

Questions about this trial

What is this clinical trial studying?

A study testing Spinal analgesia and Epidural Analgesia in people with Pruritis and Hypotension Drug-Induced, run by St. Justine's Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology (5146684778, valerie@zaphiratos.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pruritus (time frame: Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07187427, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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