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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02923869
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : September 7, 2017
Information provided by (Responsible Party):
MOHAMED F. MOSTAFA, Assiut University

Brief 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.

Condition or disease Intervention/treatment Phase
Recovery After Cleft Palate Surgery Drug: Levobupivacaine Drug: Bupivacaine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group L
Children will receive 0.15 ml/kg of 0.2% Levobupivacaine
Drug: 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
Drug: Bupivacaine
Children will receive 0.15 ml/kg of 0.2% Bupivacaine through bilateral suprazygomatic MNB.

Primary Outcome Measures :
  1. recovery after surgery [ Time Frame: 2 hours ]
    sedation of the child in the recovery room will be monitored

Secondary Outcome Measures :
  1. FLACC score [ Time Frame: 24 hours ]
    Nalbuphine will be given when visual analogue score ≥ 3

  2. Intraoperative and Postoperative Complications [ Time Frame: 24 hours ]
    percentage of patients with any complications will be recorded

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 1-10 years
  • Both sexes
  • ASA I or II
  • Primary cleft palate

Exclusion Criteria:

  • Any allergy to local anesthetics
  • Coagulation disorders
  • Local infection or injury at site of MNB
  • Concomitant rhinoplasty
  • Associated other congenital anomalies
  • History of upper or lower airway diseases
  • History of sleep apnea

Information from the National Library of Medicine

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 identifier (NCT number): NCT02923869

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Assiut university hospital
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
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Study Chair: HAMDY A YOUSSEF, MD Assiut University

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Responsible Party: MOHAMED F. MOSTAFA, Lecturer of Anesthesia and Intensive Care, Assiut University Identifier: NCT02923869    
Other Study ID Numbers: SMB Levobupivacaine
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by MOHAMED F. MOSTAFA, Assiut University:
Nerve Block
Cleft Palate
Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents