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

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

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

Study Overview

• Status: Completed
• Conditions: Cleft Lip
• Intervention / Treatment: Drug: Dexmedetomidine group; Drug: Dexamethasone group

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University Childeren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Enas Abd el Motlb, MD, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexamethasone; Dexmedetomidine
• Other Study ID Numbers: R/17.05.85

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No