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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal | Active Comparator | Intrathecal fentanyl This group will receive intrathecal BupivacaĂŻne 0.25% 1ml + Fentanyl 15mcg And epidural Nacl 0.9% |
|
| Epidural | Active Comparator | Epidural fentanyl This group will receive intrathecal BupivacaĂŻne 0.25% 1ml + NaCl 0,9% And epidural fentanyl 100mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus | Incidence et severity
| Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Vomiting | Incidence : Present or not Severity : number of patients treated (antinausea) | 2 hours until neuraxial analgesia |
| Hypotension | Incidence : Decrease of arterial systolic pressure < 20% from basal Severity : Total dose of IV ephedrine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology | Contact | 5146684778 | valerie@zaphiratos.ca | |
| Aymen Messadaa, MD, Anesthesiology | Contact | 514-603-5177 | aymen.messadaa@umontreal.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31704251 | Background | 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. | |
| 24106351 | Background |
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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.
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|
|
| 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) |
|
|
| 2 hours until neuraxial analgesia |
| Urinary rentention | Number of urinary catheterizations | 24 hours until the neuraxial analgesia |
| Maternal satisfaction | Maternal satisfaction with neuraxial analgesia using :
| 24 hours until neuraxial analgesia |
| 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. | 2 hours until neuraxial analgesia |
| 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. |
| 15321435 | 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. |
| 11012498 | 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. |
| 9477056 | 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. |
| 28067707 | 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. |
| ID | Term |
|---|---|
| D011537 | Pruritus |
| D007022 | Hypotension |
| D016055 | Urinary Retention |
| D009325 | Nausea |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D015360 | Analgesia, Epidural |
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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