Fentanyl Adverse Reaction, Fentanyl Analgesia, Fetal Bradycardia During Labor, Hypotension Drug-Induced, Labor Analgesia, Nausea and Vomitting, Neuraxial Opioid, Opioid Analgesic Adverse Reaction, Pruritis, Satisfaction, Patient, Term Labour, Urinary Retention
Conditions
Keywords
neuraxial opioid induced pruritus during labor, Intrathecal fentanyl versus Epidural fentanyl
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
Interventions
PROCEDURESpinal 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.
PROCEDUREEpidural 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)
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus | Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia | Incidence et severity * 4-point Likert scale: Absent, light, moderate, severe/unbearable. * number of patients treated by antipruritic (Naloxone) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Vomiting | 2 hours until neuraxial analgesia | Incidence : Present or not Severity : number of patients treated (antinausea) |
| Hypotension | 2 hours until neuraxial analgesia | Incidence : Decrease of arterial systolic pressure \< 20% from basal Severity : Total dose of IV ephedrine |
| Urinary rentention | 24 hours until the neuraxial analgesia | Number of urinary catheterizations |
| Maternal satisfaction | 24 hours until neuraxial analgesia | 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. |
| Fetal Bradycardia | 2 hours until neuraxial analgesia | 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. |
Countries
Canada
Contacts
Primary ContactValerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology
Backup ContactAymen Messadaa, MD, Anesthesiology
Outcome results
None listed