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

Primary Purpose

Analgesia

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine +Bupivacaine
Magnesium Sulfate + Bupivacaine
Bupivacaine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

3 Months - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaine

general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaine

general anesthesia+infraorbital nerve block by bupivacaine only

Arm Description

Outcomes

Primary Outcome Measures

first time to analgesic requirment
paracetamol will be given as the first rescue analgesia

Secondary Outcome Measures

Total amount of analgesics
pain score (FLACC Score) face, leg , cry, activity ,conslolability
assess pain in patients (ranging from 0-10, where 0 = no pain, 10 = worst pain)
postoperative side effects

Full Information

First Posted
November 14, 2022
Last Updated
May 11, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05624151
Brief Title
Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaine
Arm Type
Active Comparator
Arm Title
general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaine
Arm Type
Active Comparator
Arm Title
general anesthesia+infraorbital nerve block by bupivacaine only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine +Bupivacaine
Intervention Description
infraorbital nerve block by dexmedetomidine plus bupivacaine
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate + Bupivacaine
Intervention Description
infraorbital nerve block by magnesium sulphate plus bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
infraorbital nerve block by bupivacaine only
Primary Outcome Measure Information:
Title
first time to analgesic requirment
Description
paracetamol will be given as the first rescue analgesia
Time Frame
1st 24 hour
Secondary Outcome Measure Information:
Title
Total amount of analgesics
Time Frame
1st 24 hours postoperatively
Title
pain score (FLACC Score) face, leg , cry, activity ,conslolability
Description
assess pain in patients (ranging from 0-10, where 0 = no pain, 10 = worst pain)
Time Frame
1st 24 postoperatively
Title
postoperative side effects
Time Frame
1st 24 hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who will be scheduled for indicated cleft lip surgery. • physical status American Society of Anesthesiologists (ASA) I or II. Exclusion Criteria: 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.
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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