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Suprazygomatic Block in Cleft Palate Surgery in Children

NCT03412474 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-09-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-14
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412474 on ClinicalTrials.gov