Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery. (IFONB)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02514980 |
Recruitment Status :
Completed
First Posted : August 4, 2015
Last Update Posted : January 31, 2017
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | August 1, 2015 | ||||
First Posted Date ICMJE | August 4, 2015 | ||||
Last Update Posted Date | January 31, 2017 | ||||
Study Start Date ICMJE | August 2015 | ||||
Actual Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
postoperative analgesic consumption [ Time Frame: 24 hours postoperative ] the total consumption of analgesics in the first 24h postoperative
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery. | ||||
Official Title ICMJE | Infra-orbital Nerve Block for Post Operative Analgesia in Young Children Undergoing Pediatric Cleft Lip Surgery. | ||||
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
Condition ICMJE | Postoperative Pain | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE |
40 | ||||
Actual Study Completion Date ICMJE | August 2016 | ||||
Actual Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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. |
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 3 Months to 6 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02514980 | ||||
Other Study ID Numbers ICMJE | IRB00008718/ ref. no.103 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Hala Saad Abdel-Ghaffar, Assiut University | ||||
Study Sponsor ICMJE | Assiut University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Assiut University | ||||
Verification Date | January 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |