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Suprazygomatic Block in Cleft Palate Surgery in Children

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ClinicalTrials.gov Identifier: NCT03412474
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
RAGAA AHMED HERDAN, Assiut University

Brief Summary:

Cleft palate (CP) is a common congenital malformation, with an incidence ranging from 0.1 to 1.1 per 1000 births depending on the population group (liau et al, 2010). Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract infections (Takemura et al., 2002).

CP repair is painful, necessitating high doses of intravenous (I.V.) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 48h postoperatively (Roulleau et al, 2003).

Maxillary nerve block using the suprazygomatic approach is used in children since it presents a lower rate of complications (Captier et al, 2009). By this way, one can reach the nerve as it exits the skull at the foramen rotundum within the pterygopalatine fossa, before the location where its nervous branches innervate the palate (Prigge et al, 2014). This simple, reliable and almost risk-free approach can yield an effective and prolonged anesthesia with a clear decreased use of morphine agents during and after cleft lip-palate surgery in small children (Mesnil et al, 2010). The nerve block must be bilateral. The local anesthetic (LA) is directly injected in the middle part of the fossa at a distance from the foramen rotundum to avoid any trauma to the nerve or vascular injury, as soon as the tip of the needle has crossed the temporal muscle (Binet et al, 2015).

Various adjuvants to local anesthetics to increase the duration of block are described in the literature and used in the daily clinical practice. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Animal studies showed that perineural dexmedetomidine added to bupivacaine or ropivacaine prolongs the duration of sensory and motor block (Brummett et al, 2011). Other clinical studies investigated the use of dexmedetomidine in patients undergoing ulnar nerve, axillary brachial and greater palatine nerve blocks, showed faster onset time and longer duration of block (Marhofer et al, 2013/ Esmaoglu et al, 2010& Obayah et al, 2010).


Condition or disease Intervention/treatment Phase
Cleft Palate Drug: Bupivacaine Drug: Dexmedetomidine Drug: paracetamol Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparison of the analgesic effect of adding dexmedetomidine to bupivacaine with the analgesic effect of using bupivacaine alone in bilateral SMB for children undergoing CP repair under general anesthesia.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The trial will be planned that neither the doctors (investigators) nor the patients' guardians or even children themselves will be aware of the group allocation and drug received. The study drugs will be prepared by an anesthesiologist not involved in performing the block, patient care or in data collection.
Primary Purpose: Prevention
Official Title: Evaluation of Postoperative Analgesic Effects of Bilateral Suprazygomatic Maxillary Nerve Block Using Bupivacaine and Dexmedetomidine in Children Undergoing Cleft Palate Repair Under General Anesthesia:Randomized Controlled Trial
Actual Study Start Date : January 14, 2018
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivacaine
Patients will receive 0.2 ml/kg/side of bupivacaine (0.125%).
Drug: Bupivacaine

The study drugs will be prepared by an anesthesiologist not involved in performing the block, patient care or in data collection. Patients will be randomly allocated into two groups of 40 patients each:

Group A: will receive 0.2 ml/kg/side of bupivacaine (0.125%).


Drug: paracetamol
paracetamol

Active Comparator: Dexmedetomidine
Patients will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine.
Drug: Bupivacaine

The study drugs will be prepared by an anesthesiologist not involved in performing the block, patient care or in data collection. Patients will be randomly allocated into two groups of 40 patients each:

Group A: will receive 0.2 ml/kg/side of bupivacaine (0.125%).


Drug: Dexmedetomidine
Group B: will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine.

Drug: paracetamol
paracetamol




Primary Outcome Measures :
  1. modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) [ Time Frame: 24 hours ]
    postoperative pain assessment in children minimum score: 4, maximum score: 13 Patients with modified CHEOPS > 6 will be given rescue analgesia


Secondary Outcome Measures :
  1. time to first analgesia [ Time Frame: 24 hours ]
    time of intravenous paracetamol requirment postoperatively

  2. 5-point Likert scale [ Time Frame: 24 hours ]

    parent satisfaction score

    (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied)




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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 1 and 5 years
  • Children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts
  • Gender: both

Exclusion Criteria:

  • Parent refusal
  • History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
  • Hypersensitivity to any local anesthetics
  • Bleeding diathesis
  • Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders
  • Skin lesions or wounds at the puncture site of the proposed block

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 ClinicalTrials.gov identifier (NCT number): NCT03412474


Contacts
Contact: ahmed elminshawy, prof 2332278 ext 088 ethics_committee12@yahoo.com

Locations
Egypt
Assiut University Hospital Recruiting
Assiut, Egypt
Contact: ahmed elminshawy, prof    2332278 ext 088    ethics_committee12@yahoo.com   
Sponsors and Collaborators
Assiut University

Responsible Party: RAGAA AHMED HERDAN, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03412474     History of Changes
Other Study ID Numbers: suprazygomatic block
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RAGAA AHMED HERDAN, Assiut University:
suprazygomatic block, dexmedetomidine

Additional relevant MeSH terms:
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
Bupivacaine
Dexmedetomidine
Acetaminophen
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action