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AnalgesiaPhase 3NCT05624151

Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery

A Phase 3 study testing Dexmedetomidine +Bupivacaine, Magnesium Sulfate + Bupivacaine and Bupivacaine in people with Analgesia, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Regional analgesia is considered the cornerstone for postoperative analgesia in paediatric patients. One of the most common birth defects which require surgical intervention early in life is the cleft lip. Infraorbital nerve block (IONB) has been used for postoperative analgesia in this delicate and sensitive area. Read more about this study

Who is it for?
Ages 3 months to 7 years
Conditions the study is for
Analgesia
What is being tested?
Dexmedetomidine +Bupivacaine, Magnesium Sulfate + Bupivacaine and Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteEgypt
Study dates
25 Nov 2022to 2 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • patients who will be scheduled for indicated cleft lip surgery. • physical status American Society of Anesthesiologists (ASA) I or II.

Who cannot join

  • failure to gain the consent from parents
  • allergy to any of drugs used
  • coagulopathy
  • thrombocytopenia
  • history of any lower or upper airway disorders
  • history of sleep apnea syndrome with a suspected need for postoperative ventilation
  • any wound or infection related to puncture site
  • major illness failure to gain the consent of parents.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams University hospitals

    Cairo

Other trials in Egypt

About this study

Official title: Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery: A Prospective, Randomized Double Blinded Study

Regional analgesia is considered the cornerstone for postoperative analgesia in paediatric patients. One of the most common birth defects which require surgical intervention early in life is the cleft lip. Infraorbital nerve block (IONB) has been used for postoperative analgesia in this delicate and sensitive area.

As the assessment of pain may be very challenging especially in young children, the local anaesthetics administration can be a safe alternative to opioids.[2] However, the regional block after a single dose of local anaesthetic is of limited duration and efficacy. Hence, the coadministration of adjuvants with local anaesthetics may be helpful for potentiation of analgesic effect.

Read more

Infraorbital nerve block is a well-recognized regional anaesthetic technique which can provide intraoperative and postoperative pain relief in nasal endoscopic surgery and in some types of oral and dental surgery including cleft lip repair . The block may also be used to help diagnose neuralgia arising from the second division of the trigeminal nerve. The technique for infraorbital nerve blockade is most performed as it exits the infraorbital foramen just below the inferior orbital rim.Dexmedetomidine (DE) is a potent α2 adrenoreceptor agonist and it is highly selective for α2 adrenoreceptor seven times more than clonidine. Many studies documented a prolonged duration and rapid onset of sensory block with the perineural injection of DE. Dexmedetomidine has been introduced as an adjuvant to local anaesthetics in both neuroaxial and peripheral nerve blocks. [9, 10] perineural dexmedetomidine has shown to prolong the duration of postoperative analgesia in addition to reducing the opioid consumption. The exact mechanism of peripheral nerve block produced by α2 adrenoreceptor agonists includes central analgesia, anti-inflammatory effect.Another suggested mechanism is that DE may exert its action through blocking the hyperpolarization-activated cation current after the transient sodium influx. The effect of magnesium was first recognized for the treatment of arrhythmia and preeclampsia, and its effect on anaesthesia and analgesia has recently been recognized. Magnesium sulphate has also been used as an adjunct to anaesthesia in recent years. It is also an effective analgesic agent for perioperative pain. Research have also reported that the intraoperative use of magnesium is characterized by a reduced use of anaesthetics and muscle relaxants. Furthermore, opioid use, postoperative nausea and vomiting, hypertension, and shivering have met a decreased trend with the use of magnesium sulphate. In a study performed by (El-Emam and El motlb) in 2019 they compared the efficacy of dexamethasone versus dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided infraorbital nerve block in paediatric patients scheduled for cleft lip repair. they noticed that dexmedetomidine produced a more prolonged duration of analgesia and a lower pain score and increased sedation than produced by dexamethasone. Also, they found that Both dexamethasone and dexmedetomidine were tolerable with no significant difference regarding the incidence of postoperative nausea and vomiting or intraoperative hemodynamic changes.Aim of the work:

The purpose of this randomized controlled double-blind study is to compare the efficacy of Dexmedetomidine or Magnesium sulphate as adjuvants for bupivacaine in infraorbital nerve block in paediatric patients scheduled for cleft lip repair.

Conditions
Analgesia
Being tested
Dexmedetomidine +Bupivacaine, Magnesium Sulfate + Bupivacaine, Bupivacaine
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine +BupivacaineDrug

    infraorbital nerve block by dexmedetomidine plus bupivacaine

  • Magnesium Sulfate + BupivacaineDrug

    infraorbital nerve block by magnesium sulphate plus bupivacaine

  • BupivacaineDrug

    infraorbital nerve block by bupivacaine only

Study groups in NCT05624151
Study groupRoleWhat they receive
general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaineActive comparatorNot described
Receives: Drug: Dexmedetomidine +Bupivacaine
general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaineActive comparatorNot described
Receives: Drug: Magnesium Sulfate + Bupivacaine
general anesthesia+infraorbital nerve block by bupivacaine onlyActive comparatorNot described
Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. first time to analgesic requirment

    paracetamol will be given as the first rescue analgesia

    Measured: 1st 24 hour

Secondary outcomes (3)
  1. Total amount of analgesics

    Measured: 1st 24 hours postoperatively

  2. pain score (FLACC Score) face, leg , cry, activity ,conslolability

    assess pain in patients (ranging from 0-10, where 0 = no pain, 10 = worst pain)

    Measured: 1st 24 postoperatively

  3. postoperative side effects

    Measured: 1st 24 hour postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start25 Nov 2022
  3. Primary completion2 May 2023
  4. Study completion2 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624151
Sponsor's protocol ID
R176/2022
Status last verified
May 2023
First submitted
14 Nov 2022
Last updated
15 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine +Bupivacaine, Magnesium Sulfate + Bupivacaine and Bupivacaine in people with Analgesia, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

first time to analgesic requirment (time frame: 1st 24 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

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