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

Phase 4

Completed

• Conditions: Cleft Lip
• Interventions: Drug: Dexamethasone group; Drug: Dexmedetomidine group

• Registration Number: NCT03480607
• Lead Sponsor: Mansoura University

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.

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 Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-29
• Primary Completion: 2018-04-30
• Study Completion: 2018-05-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone group	Dexamethasone group	Dexamethasone in conjunction with bupivacaine f
Dexmedetomidine group	Dexmedetomidine group	Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Heart rate	For 4 hours after induction	(beat/min)
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.
Systolic blood pressure	For 4 hours after induction	(mmHg)
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

Trial Locations

Locations (1)

Mansoura University Childeren Hospital; 🇪🇬 Mansourah, DK, Egypt