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

Postoperative Pain Clinical Trial

— IFONB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514980
• Other study ID #: IRB00008718/ ref. no.103
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 1, 2015
• Last updated: January 28, 2017
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine
Infraorbital nerve block using bupivacaine 0.25% on each side.
• Ketamine
Infraorbital nerve block using 0.5mg/kg ketamine on each side.

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut	Assiut governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative analgesic consumption	the total consumption of analgesics in the first 24h postoperative	24 hours postoperative
Secondary	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.	24 h postoperative.
Secondary	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).	24 h postoperative