Not yet recruiting NCT07187427
Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal analgesia, Epidural Analgesia.
- Who it may be relevant to
- Registry conditions: Pruritis, Hypotension Drug-Induced, Urinary Retention, Fetal Bradycardia During Labor. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Trial Comparing the Injection of Intrathecal Fentanyl Versus Epidural Fentanyl for the Initiation of Labour Analgesia on the Incidence of Pruritis.
Overview
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
Interventions
- Procedure 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 - 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
Primary outcome measures
- Pruritus [Time frame: Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia]
Secondary outcome measures (5)
- Nausea Vomiting [Time frame: 2 hours until neuraxial analgesia]
- Hypotension [Time frame: 2 hours until neuraxial analgesia]
- Urinary rentention [Time frame: 24 hours until the neuraxial analgesia]
- Maternal satisfaction [Time frame: 24 hours until neuraxial analgesia]
- Fetal Bradycardia [Time frame: 2 hours until neuraxial analgesia]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Centre Hospitalier Universitaire de Sainte Justine — Montreal
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28067707
Identifiers
NCT: NCT07187427 · 2026-9304