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

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Cleft Lip

Treatments: Drug: Dexamethasone group; Drug: Dexmedetomidine group

Study type: Interventional

Funder types: Other

Identifiers

NCT03480607

R/17.05.85

Details and patient eligibility

About

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

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 1 month to 1 year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Dexmedetomidine group

Active Comparator group

Description:

Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block

Treatment:

Drug: Dexmedetomidine group

Dexamethasone group

Active Comparator group

Description:

Dexamethasone in conjunction with bupivacaine f

Treatment:

Drug: Dexamethasone group