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Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery. (IFONB)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine
Ketamine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

3 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(ASA) physical status I and II aged less than 2 years undergoing elective cleft lip repair (with or without cleft palate) under general anesthesia.

Exclusion Criteria:

Patients with local infection at the site of injection of block, history suggestive of drug allergy, any systemic disease that compromises the cardiovascular, respiratory or neurological function, other congenital anomaly, history of upper or lower airway disease, coagulation disorders, and children with history of sleep apnea and in whom postoperative ventilation may be required will be excluded from the study.

Sites / Locations

  • Assiut university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacaine group

Bupivacaine-Ketamine group.

Arm Description

Infraorbital nerve block using bupivacaine 0.25% on each side.

Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.

Outcomes

Primary Outcome Measures

postoperative analgesic consumption
the total consumption of analgesics in the first 24h postoperative

Secondary Outcome Measures

Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score
FLACC pain score will be recorded on arrival to the recovery room (0) and at 1, 2, 3, 4, 8, 12, and 24 hours postoperative.
Parent satisfaction score
The parents will be asked to evaluate their satisfaction regarding pain control at the end of 24 hours over a score of 4 points (1=bad, 2=moderate, 3=good, 4=excellent).

Full Information

First Posted
August 1, 2015
Last Updated
January 28, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02514980
Brief Title
Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery.
Acronym
IFONB
Official Title
Infra-orbital Nerve Block for Post Operative Analgesia in Young Children Undergoing Pediatric Cleft Lip Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
this study will be undertaken to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.
Detailed Description
Oro-facial clefts are the most prevalent craniofacial birth defects and the second most common birth anomaly, second only to clubfoot [Strong & Buckmiller 2001]. Cleft lip surgery is associated with appreciable postoperative pain in children Alleviation of postoperative pain is important in these patients. The fear of respiratory depression using opioids has renewed the interest in regional anesthesia to provide safe and effective postoperative analgesia. Infra-orbital nerve block has been advocated as a suitable local analgesic technique for cleft lip surgery and superficial surgery on the mid face [Morton 2004, Takmaz et al. 2009, Rajesh et al. 2011, Jindal et al. 2011].The infra-orbital nerve supplies the upper lip, lower eyelid, and adjacent skin of the cheek and nose. Unilateral or bilateral infra-orbital nerve block has been performed with a very high success rate. The investigators designed this study to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine group
Arm Type
Active Comparator
Arm Description
Infraorbital nerve block using bupivacaine 0.25% on each side.
Arm Title
Bupivacaine-Ketamine group.
Arm Type
Active Comparator
Arm Description
Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
bucaine
Intervention Description
Infraorbital nerve block using bupivacaine 0.25% on each side.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Katalar
Intervention Description
Infraorbital nerve block using 0.5mg/kg ketamine on each side.
Primary Outcome Measure Information:
Title
postoperative analgesic consumption
Description
the total consumption of analgesics in the first 24h postoperative
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score
Description
FLACC pain score will be recorded on arrival to the recovery room (0) and at 1, 2, 3, 4, 8, 12, and 24 hours postoperative.
Time Frame
24 h postoperative.
Title
Parent satisfaction score
Description
The parents will be asked to evaluate their satisfaction regarding pain control at the end of 24 hours over a score of 4 points (1=bad, 2=moderate, 3=good, 4=excellent).
Time Frame
24 h postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (ASA) physical status I and II aged less than 2 years undergoing elective cleft lip repair (with or without cleft palate) under general anesthesia. Exclusion Criteria: Patients with local infection at the site of injection of block, history suggestive of drug allergy, any systemic disease that compromises the cardiovascular, respiratory or neurological function, other congenital anomaly, history of upper or lower airway disease, coagulation disorders, and children with history of sleep apnea and in whom postoperative ventilation may be required will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdel-Ghaffar, MD
Organizational Affiliation
Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
State/Province
Assiut governorate
ZIP/Postal Code
715715
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a single center study with no plan to share data

Learn more about this trial

Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery.

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