Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair
Study Details
Study Description
Brief Summary
To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dexmedetomidine group Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block |
Drug: Dexmedetomidine group
0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine
|
| Active Comparator: Dexamethasone group Dexamethasone in conjunction with bupivacaine f |
Drug: Dexamethasone group
0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone
|
Outcome Measures
Primary Outcome Measures
- Postoperative FLACC scale [for 24 hours after surgery]
FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,
- Postoperative sedation score [for 4 hours after surgery]
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,
Secondary Outcome Measures
- Heart rate [For 4 hours after induction]
(beat/min)
- Systolic blood pressure [For 4 hours after induction]
(mmHg)
- Postoperative nausea [for 24 hours after surgery]
As nausea can't be detected in this age group; so we will detect only if vomiting occur or not and number of attacks.
- Haematoma formation after surgery [for 24 hours after surgery]
That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation
- Postoperative vomiting [for 24 hours after surgery]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura University Childeren Hospital | Mansourah | DK | Egypt | 050 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Study Chair: Enas Abd el Motlb, MD, Mansoura University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R/17.05.85