Comparison of two anaesthetics used in scheduled caesarean section in terms of post anaesthesia immobilisation duration : hyperbaric Prilocaïne versus hyperbaric Bupivacaïne.

Comparison of motor blockade duration in the context of scheduled caesarean section with spinal anaesthesia : hyperbaric Prilocaïne versus hyperbaric Bupivacaïne. - Césarcaïne

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002921-39-FR

Enrollment

Registered

2018-01-12

Start date

2017-12-11

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean section anaesthesia

Interventions

Trade Name: BARITEKAL® (Prilocaïne) Product Name: BARITEKAL® Pharmaceutical Form: Solution for injection INN or Proposed INN: PRILOCAINE CAS Number: 721-50-6 Concentration unit: mg/ml milligram(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Scheduled C-section - Eutocic pregnancy - Non-multiple pregnancy - Age : over 18-years-old - Height : between 155cm and 175cm - Patient affiliated or beneficiary of healthcare protection - Signature of consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Underage patient - Pathological pregnancy - Multiple pregnancy - Emergency C-section - Patient not speaking french - Patient refusal - spinal anaesthesia contraindication : .Cutaneous infection at the injection point .Sepsis .Coagulation disorder .Lumbar equipment at needle-puncture site - Prilocaïne contraindication : .Allergy to Prilocaine or other amide local anaesthetic, or allergy to any excipient of BARITEKAL® .Severe cardiac conduction abnormality .Severe anaemia .Decompensated heart failure .Cardiogenic and hypovolemic shock .Congenital or acquired methemoglobinemia .Concomitant treatment by blood thinner .Methemoglobinemia contributing factors (Dapsone, Cotrimoxazole, antimalarial treatments, nitroprusside, nitrates, nitrofurane, oxyde nitrique, 8-hydrosiquinoleine, phenacetin, phenazorydine, resercine) - Bupivacaïne contraindication : .Allergy to local amide anesthetic .IV local anaesthesia

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the duration of the motor blockade after spinal anaesthesia with Bupivacaine or Prilocaine in the context of scheduled C-sections (time between the anaesthesia and the Bromage score = 0);Secondary Objective: 1) superior sensitivity level 15mn after injection (cold test) 2) Néosynéphrine injected quantity to correct hypotensions (arterial pressure < 90/60mmHg or nausea or vomiting) 3) newborn APGAR score at birth 4) delay between injection and incision 5) surgery duration (time between incision and last suture) 6) post-operatoire necessity for complementary anaesthetic 7) delay before the first dose of emergency analgesic 8) pos-operative pain 9) delay before the patient is back to her room 10) presence/absence of post-lumbar ponction syndrome 11) patient's satisfaction survey at 24h (ENS between 0 and 10) 12) surgeon's satisfaction survey at the end of the surgery about the spinal anaesthesia (ENS between 0 and 10);Primary end point(s): Motor blockade duration measure by Bromage score;Timepoint(s) of evaluation of this end point: every 15mn from the begining of the anaesthesia until the score reaches 0	—

Measure

Time frame

Main Objective: To compare the duration of the motor blockade after spinal anaesthesia with Bupivacaine or Prilocaine in the context of scheduled C-sections (time between the anaesthesia and the Bromage score = 0);Secondary Objective: 1) superior sensitivity level 15mn after injection (cold test) 2) Néosynéphrine injected quantity to correct hypotensions (arterial pressure < 90/60mmHg or nausea or vomiting) 3) newborn APGAR score at birth 4) delay between injection and incision 5) surgery duration (time between incision and last suture) 6) post-operatoire necessity for complementary anaesthetic 7) delay before the first dose of emergency analgesic 8) pos-operative pain 9) delay before the patient is back to her room 10) presence/absence of post-lumbar ponction syndrome 11) patient's satisfaction survey at 24h (ENS between 0 and 10) 12) surgeon's satisfaction survey at the end of the surgery about the spinal anaesthesia (ENS between 0 and 10);Primary end point(s): Motor blockade duration measure by Bromage score;Timepoint(s) of evaluation of this end point: every 15mn from the begining of the anaesthesia until the score reaches 0

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Secondary

Measure	Time frame
Secondary end point(s): 1) Sensory level (cold test) 2) Quantoty of Neosynephrine needed to correct the hypotensions (arterial pressure < 90/60mmHg, nausea, vomitting) 3) delay between the spinal anaesthesia and the first incision 4) newborn APGAR score 5) duration of the intervention 6) pain level (Visual Analog Scale VAS) 7) delay between spinal anaesthesia and the first injection of second line analgesic 8) delay before the patient is back to her chamber 9) Presence of neurosensory disorders 10) Presence of post lumbar puncture syndrome 11) patient's satisfaction (simple numerical scale) 12) surgeon's satisfaction about the spinal anaesthesia (simple numerical scale from 0 to 10);Timepoint(s) of evaluation of this end point: 1) at 5, 10 and 15mn after the injection of the anaesthetic and at the end of the intervention 2) when the patient leaves the service 3) at the time of the first cut 4) at birth 5) time between the first incision and the last stiches 6) when arriving and leaving the post anesthesia care units (PACU) and at H24 7) At the injection of the second line analgesic 8) When the patient is back to her room 9) in the 24h after surgery 10) at H24 11) at H24 12) at the end of the surgery	—

Measure

Time frame

Secondary end point(s): 1) Sensory level (cold test) 2) Quantoty of Neosynephrine needed to correct the hypotensions (arterial pressure < 90/60mmHg, nausea, vomitting) 3) delay between the spinal anaesthesia and the first incision 4) newborn APGAR score 5) duration of the intervention 6) pain level (Visual Analog Scale VAS) 7) delay between spinal anaesthesia and the first injection of second line analgesic 8) delay before the patient is back to her chamber 9) Presence of neurosensory disorders 10) Presence of post lumbar puncture syndrome 11) patient's satisfaction (simple numerical scale) 12) surgeon's satisfaction about the spinal anaesthesia (simple numerical scale from 0 to 10);Timepoint(s) of evaluation of this end point: 1) at 5, 10 and 15mn after the injection of the anaesthetic and at the end of the intervention 2) when the patient leaves the service 3) at the time of the first cut 4) at birth 5) time between the first incision and the last stiches 6) when arriving and leaving the post anesthesia care units (PACU) and at H24 7) At the injection of the second line analgesic 8) When the patient is back to her room 9) in the 24h after surgery 10) at H24 11) at H24 12) at the end of the surgery

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Countries

France

Contacts

Public ContactVerchère Anne

University Hospital of Montpellier

a-verchere@chu-montpellier.fr0033467330812

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026