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

• ClinicalTrials.gov Identifier: NCT02514980
• Recruitment Status: Completed
• First Posted: August 4, 2015
• Last Update Posted: January 31, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Hala Saad Abdel-Ghaffar, Assiut University

Tracking Information

• First Submitted Date: August 1, 2015
• First Posted Date: August 4, 2015
• Last Update Posted Date: January 31, 2017
• Study Start Date: August 2015
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2015)

postoperative analgesic consumption [ Time Frame: 24 hours postoperative ]

the total consumption of analgesics in the first 24h postoperative

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 3, 2015)

• Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score [ Time Frame: 24 h postoperative. ]
  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 [ Time Frame: 24 h postoperative ]
  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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Postoperative Pain

Intervention

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

Study Arms

• Active Comparator: Bupivacaine group
  Infraorbital nerve block using bupivacaine 0.25% on each side.
  Intervention: Drug: Bupivacaine
• Active Comparator: Bupivacaine-Ketamine group.
  Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.
  Interventions:

  • Drug: Bupivacaine
  • Drug: Ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 22, 2016): 30
• Original Estimated Enrollment (submitted: August 3, 2015): 40
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Months to 6 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT02514980
• Other Study ID Numbers: IRB00008718/ ref. no.103
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

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

• Responsible Party: Hala Saad Abdel-Ghaffar, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hala S Abdel-Ghaffar, MD; Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt

• PRS Account: Assiut University
• Verification Date: January 2017