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Analgesic contribution of the suprazygomatic maxillary nerve block after cleft palate surgery in children

Analgesic contribution of the suprazygomatic maxillary nerve block after cleft palate surgery in children - Suprazyg

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2018-001457-28-FR
Enrollment
74
Registered
2019-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

cleft palate repair surgery with or without upper lip surgery

Interventions

Product Name: levobupivacaine Product Code: ATC N01B B10 Pharmaceutical Form: Solution for injection

Sponsors

CHU Amiens-Picardie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: children between 6 month and 12yo (>5kg) undergoing cleft palate repair surgery with or without upper lip surgery Are the trial subjects under 18? yes Number of subjects for this age range: 74 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: inappropriate age, weight <5kg, abnormal blood coagulation, local anesthetic contraindication, local infection.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: To compare between two groups: • the evaluation of the consumption of perioperative morphine • the evaluation of the scales of pain at different defined times • the evaluation of the number of episodes of respiratory distres • the evaluation of the period of re-feeding • the evaluation of the duration of hospitalization • the complications due to nerve block;Main Objective: compare the consumption of morphine during the first 48 hours after cleft palate surgery in a group of patients treated by realization of a suprazygomatic maxillary nerve block, compared to a control group;Primary end point(s): amount of morphine consumed during the 48 hours post surgery;Timepoint(s) of evaluation of this end point: 48 hours postoperative—

Secondary

MeasureTime frame
Secondary end point(s): - amount of morphine consumed during the surgery - scales of pain at different defined times, - the number of episodes of respiratory distress, - the feed time, - the length of stay;Timepoint(s) of evaluation of this end point: Between the surgery and 30 days after the surgery—

Countries

France

Contacts

Public ContactCOLLIN Arnaud

CHU Amiens-Picardie

collin.arnaud@chu-amiens.fr33322088371

Outcome results

None listed

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