About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Vaginal delivery
Gestational age ≥ 37 weeks
Requesting neuraxial analgesia
Disqualifiers
ASA score > 3
Allergy or contraindication to receiving opioids/local anesthesia (morphine or fentanyl)
BMI > 40 kg/m²
Hepatic or renal failure,
Trial design
Parallel
Treatments tested in this trial
Spinal analgesia
Procedure/SurgeryAll 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 Analgesia
Procedure/SurgeryAll 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)
Treatment groups
Trial outcomes
Primary outcomes
Pruritus
Incidence et severity * 4-point Likert scale: Absent, light, moderate, severe/unbearable. * number of patients treated by antipruritic (Naloxone)
Secondary outcomes
Nausea Vomiting
Incidence : Present or not Severity : number of patients treated (antinausea)
Hypotension
Incidence : Decrease of arterial systolic pressure \< 20% from basal Severity : Total dose of IV ephedrine
Urinary rentention
Number of urinary catheterizations
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.
Sponsors and contacts
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