Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair

Study Overview
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Brief Summary
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To assess the efﬁcacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.

Detailed Description
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Regarding patient registry; A prior G power analysis was done. Using the results obtained from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases is expected, so; 22 cases per group will be required. Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Official Title
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Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair

Conditions
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Cleft Lip

Intervention / Treatment
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* Drug: Dexmedetomidine group
* Drug: Dexamethasone group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American society of anesthesiologist (ASA) physical status I or II Exclusion Criteria: known allergy to any of drugs used coagulopathy any wound or infection related to puncture site major illness failure to gain consent of parents.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine group<br>Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block | Drug: Dexmedetomidine group<br>* 0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine<br>|
| Active Comparator: Dexamethasone group<br>Dexamethasone in conjunction with bupivacaine f | Drug: Dexamethasone group<br>* 0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative FLACC scale | FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both, | for 24 hours after surgery | 
| Postoperative sedation score | The degree of sedation will be assessed by using a three point sedation scale based on eye opening: - Alert with spontaneous eye opening 0, - Drowsy with eyes only opening in response to speech 1, - Sedated with eyes opening in response to physical stimulation 2, | for 4 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | (beat/min) | For 4 hours after induction | 
| Systolic blood pressure | (mmHg) | For 4 hours after induction | 
| Postoperative nausea | As nausea can't be detected in this age group; so we will detect only if vomiting occur or not and number of attacks. | for 24 hours after surgery | 
| Haematoma formation after surgery | That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation | for 24 hours after surgery | 
| Postoperative vomiting |  | for 24 hours after surgery |