Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery
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|ClinicalTrials.gov Identifier: NCT02923869|
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : September 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Recovery After Cleft Palate Surgery||Drug: Levobupivacaine Drug: Bupivacaine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: Group L
Children will receive 0.15 ml/kg of 0.2% Levobupivacaine
Children will receive 0.15 ml/kg of 0.2% Levobupivacaine through bilateral suprazygomatic MNB.
Active Comparator: Group B
Children will receive 0.15 ml/kg of 0.2% Bupivacaine
Children will receive 0.15 ml/kg of 0.2% Bupivacaine through bilateral suprazygomatic MNB.
- recovery after surgery [ Time Frame: 2 hours ]sedation of the child in the recovery room will be monitored
- FLACC score [ Time Frame: 24 hours ]Nalbuphine will be given when visual analogue score ≥ 3
- Intraoperative and Postoperative Complications [ Time Frame: 24 hours ]percentage of patients with any complications will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923869
|Assiut university hospital|
|Assiut, Egypt, 71515|
|Study Chair:||HAMDY A YOUSSEF, MD||Assiut University|