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.
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.
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 group | Role | What they receive |
|---|---|---|
| general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaine | Active comparator | Not described Receives: Drug: Dexmedetomidine +Bupivacaine |
| general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaine | Active comparator | Not described Receives: Drug: Magnesium Sulfate + Bupivacaine |
| general anesthesia+infraorbital nerve block by bupivacaine only | Active comparator | Not described Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
first time to analgesic requirment
paracetamol will be given as the first rescue analgesia
Measured: 1st 24 hour
Secondary outcomes (3)
Total amount of analgesics
Measured: 1st 24 hours postoperatively
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
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.
- First posted21 Nov 2022
- Study start25 Nov 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05624151
- Acronym / sponsor ID
- R176/2022
- Conditions
- Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaine | Active comparator | Drug: Dexmedetomidine +Bupivacaine |
| general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaine | Active comparator | Drug: Magnesium Sulfate + Bupivacaine |
| general anesthesia+infraorbital nerve block by bupivacaine only | Active comparator | Drug: Bupivacaine |
Who may qualify
- Ages
- 3 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients who will be scheduled for indicated cleft lip surgery. • physical status American Society of Anesthesiologists (ASA) I or II.
Key exclusion criteria (8 listed)
- failure to gain the consent from parents
- allergy to any of drugs used
- coagulopathy
- thrombocytopenia
- history of any lower or upper airway disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine +Bupivacaineinfraorbital nerve block by dexmedetomidine plus bupivacaine | Drug | general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaine |
| Magnesium Sulfate + Bupivacaineinfraorbital nerve block by magnesium sulphate plus bupivacaine | Drug | general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaine |
| Bupivacaineinfraorbital nerve block by bupivacaine only | Drug | general anesthesia+infraorbital nerve block by bupivacaine only |
Primary outcome
first time to analgesic requirment
Time frame: 1st 24 hour
paracetamol will be given as the first rescue analgesia
3 secondary outcomes
Total amount of analgesics
Time frame: 1st 24 hours postoperatively
pain score (FLACC Score) face, leg , cry, activity ,conslolability
Time frame: 1st 24 postoperatively
postoperative side effects
Time frame: 1st 24 hour postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.