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Nerve blocks may cut opioid use in newborn cleft lip repair

NCT ID NCT06067854

Knowledge-focused Sponsor: Brno University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed study looked at 111 newborns who had cleft lip repair surgery. Researchers compared those who received a regional nerve block for pain relief to those who did not. The goal was to see if the nerve block reduced the amount of opioid pain medicine needed during and after surgery. The study also checked for complications and how soon babies could eat after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the nerve block reduces opioid use, it could point to safer pain management for newborns after cleft lip repair.
What could go wrong
This is a small, retrospective study, so it can't prove cause and effect. Results may not apply to all newborns or other surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

111 people

The number who actually took part.

Started

Jan 2018

Finished

Jan 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Neonates with cleft lips who underwent primary cleft lip repair surgery in tertiary center paediatric anesthesiology department

Ages

0 to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * neonates with unilateral or bilateral cleft lip (U/BCL), all neonates with unilateral or bilateral cleft lip and alveolus (U/BCLA) or with unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent cleft lip repair surgery in the neonatal period * the study period (1/2018-12/2021) Exclusion Criteria: * ● presence of coagulopathy * thrombocytopenia or thrombopathy * patients at risk of malignant hyperthermia * patients who were not neonates (older than 28 days) * patients who required postoperative mechanical ventilation

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip and alveolus cleft lip/palate

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perioperative analgesia in neonates

Contacts and locations

Locations

  • Brno University Hospital

    Brno, South Moravian, 62500, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.