Suprazygomatic Block in Cleft Palate Surgery in Children

NCT03412474 | Completed Phase 2

• 1 other identifier: suprazygomatic block
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Cleft Palate

Keywords

suprazygomatic block, dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)

  postoperative pain assessment in children minimum score: 4, maximum score: 13 Patients with modified CHEOPS \> 6 will be given rescue analgesia

  24 hours

Secondary Outcomes (2)

• time to first analgesia

  24 hours

• 5-point Likert scale

  24 hours

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Patients will receive 0.2 ml/kg/side of bupivacaine (0.125%).

Drug: Bupivacaine; Drug: paracetamol

Dexmedetomidine

ACTIVE COMPARATOR

Patients will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine.

Drug: Bupivacaine; Drug: Dexmedetomidine; Drug: paracetamol

Interventions

Bupivacaine DRUG

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%).

Bupivacaine; Dexmedetomidine

Dexmedetomidine DRUG

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

Dexmedetomidine

paracetamol DRUG

paracetamol

Bupivacaine; Dexmedetomidine

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Cleft Palate

Interventions

Bupivacaine; Dexmedetomidine; Acetaminophen

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; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: January 14, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)