Clinical trial NCT02514980: Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery.
Official title: Infra-orbital Nerve Block for Post Operative Analgesia in Young Children Undergoing Pediatric Cleft Lip Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: postoperative analgesic consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score
timeFrame: 24 h postoperative.
measure: Parent satisfaction score
timeFrame: 24 h postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut governorate
Study officials:
affiliation: Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: