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Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery

NCT02923869 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-09-07

No results posted yet for this study

Summary

A cleft deformity of the lip and/or palate is one of the commonest major birth defects.

Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its peculiarity lies in the numerous care management protocols proposed according to the surgical techniques used, operating time (between M3 and M18 of life), anesthetic technique and postoperative management.

This surgery must be associated to a specific care management because of potential associated complications, especially the risk of obstruction of the upper respiratory tract and respiratory distress majored by the use of morphine anesthetics during and after surgery.

Adequate postoperative analgesia in children is a vital part of perioperative care. Regional block given preoperatively in combination with general anesthesia (GA) provides good preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and complete recovery and reduced analgesic requirement in the postoperative period.

CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 24-h postoperative period. Cleft palate surgery is not only painful, but may also compromise the airway, particularly in children with craniofacial syndromes. Opiate analgesia has the potential to further compromise the airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is performed using a suprazygomatic approach and is based on a computer tomography study.

The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus, and the posterior nasal cavity. Maxillary nerve block (MNB) through the infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve block has led to complications such as orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury.

Conditions

  • Recovery After Cleft Palate Surgery

Interventions

DRUG

Levobupivacaine

Children will receive 0.15 ml/kg of 0.2% Levobupivacaine through bilateral suprazygomatic MNB.

DRUG

Bupivacaine

Children will receive 0.15 ml/kg of 0.2% Bupivacaine through bilateral suprazygomatic MNB.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • HAMDY A YOUSSEF, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02923869 on ClinicalTrials.gov