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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSt. Justine's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Spinal analgesia

    Procedure/Surgery

    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 Analgesia

    Procedure/Surgery

    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)

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: SpinalActive comparator 1 intervention
Group B: EpiduralActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pruritus

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

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

Secondary outcomes

1

Nausea Vomiting

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

Time frame
2 hours until neuraxial analgesia
2

Hypotension

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

Time frame
2 hours until neuraxial analgesia
3

Urinary rentention

Number of urinary catheterizations

Time frame
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.

Time frame
24 hours until neuraxial analgesia

Other outcomes

Sponsors and contacts

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