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

Primary Purpose

Cleft Lip

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine group

Dexamethasone group

About this trial

This is an interventional supportive care trial for Cleft Lip

Eligibility Criteria

1 Month - 1 Year (Child)All SexesDoes not accept 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.

Sites / Locations

Mansoura University Childeren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Dexmedetomidine group

Dexamethasone group

Arm Description

Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block

Dexamethasone in conjunction with bupivacaine f

Outcomes

Primary Outcome Measures

Postoperative FLACC scale

FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,

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,

Secondary Outcome Measures

Heart rate

(beat/min)

Systolic blood pressure

(mmHg)

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.

Haematoma formation after surgery

That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation

Postoperative vomiting

Full Information

NCT ID

NCT03480607

First Posted

March 7, 2018

Last Updated

September 3, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03480607

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

April 30, 2018 (Actual)

Study Completion Date

May 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cleft Lip

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine group

Arm Type

Active Comparator

Arm Description

Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block

Arm Title

Dexamethasone group

Arm Type

Active Comparator

Arm Description

Dexamethasone in conjunction with bupivacaine f

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine group

Intervention Description

0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine

Intervention Type

Drug

Intervention Name(s)

Dexamethasone group

Intervention Description

0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone

Primary Outcome Measure Information:

Title

Postoperative FLACC scale

Description

FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,

Time Frame

for 24 hours after surgery

Title

Postoperative sedation score

Description

Time Frame

for 4 hours after surgery

Secondary Outcome Measure Information:

Title

Heart rate

Description

(beat/min)

Time Frame

For 4 hours after induction

Title

Systolic blood pressure

Description

(mmHg)

Time Frame

For 4 hours after induction

Title

Postoperative nausea

Description

As nausea can't be detected in this age group; so we will detect only if vomiting occur or not and number of attacks.

Time Frame

for 24 hours after surgery

Title

Haematoma formation after surgery

Description

That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation

Time Frame

for 24 hours after surgery

Title

Postoperative vomiting

Time Frame

for 24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enas Abd el Motlb, MD

Organizational Affiliation

Mansoura University

Official's Role

Study Chair

Facility Information:

Facility Name

Mansoura University Childeren Hospital

City

Mansourah

State/Province

ZIP/Postal Code

050

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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