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

NCT02923869 | Completed Phase 2 DMC

• 1 other identifier: SMB Levobupivacaine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Recovery After Cleft Palate Surgery

Keywords

Levobupivacaine; Bupivacaine; Nerve Block; Cleft Palate

Outcome Measures

Primary Outcomes (1)

• recovery after surgery

  sedation of the child in the recovery room will be monitored

  2 hours

Secondary Outcomes (2)

• FLACC score

  24 hours

• Intraoperative and Postoperative Complications

  24 hours

Study Arms (2)

Group L

ACTIVE COMPARATOR

Children will receive 0.15 ml/kg of 0.2% Levobupivacaine

Drug: Levobupivacaine

Group B

ACTIVE COMPARATOR

Children will receive 0.15 ml/kg of 0.2% Bupivacaine

Drug: Bupivacaine

Interventions

Levobupivacaine DRUG

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

Group L

Bupivacaine DRUG

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

Group B

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Cleft Palate

Interventions

Levobupivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• HAMDY A YOUSSEF, MD

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 5, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

EG (1)