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

Cleft Lip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480607
• Other study ID #: R/17.05.85
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: May 10, 2018

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 10, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip

Intervention

Drug:
• Dexmedetomidine group
0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine
• Dexamethasone group
0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone

Locations

Country	Name	City	State
Egypt	Mansoura University Childeren Hospital	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Heart rate	(beat/min)	For 4 hours after induction
Secondary	Systolic blood pressure	(mmHg)	For 4 hours after induction
Secondary	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
Secondary	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
Secondary	Postoperative vomiting		for 24 hours after surgery