Clinical trial NCT05530811: Dexamethasone as Adjuvant to Bupivacaine in Suprazygomatic Maxillary Nerve Block
Official title: Comparative Study Between Dexamethasone Plus Bupivacaine Versus Bupivacaine in Management of Suprazygomatic Maxillary Nerve Block in Cleft Palate Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC) is the primary outcome. The secondary outcomes are the first-time requested analgesia, the number of children required analgesia, the total amount of analgesic requirements during first the 24 hours.

Detailed description: Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births , requiring early surgery, during the first months of life. The surgical procedure can be complicated by airway obstruction and respiratory complications. CP is painful in the first 24-48 hours following surgery.

Different treatment modalities have been used for reducing or ameliorating the pain following cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory drugs (NSAIDs). However, the analgesic drugs may provide inadequate analgesia and have side effects such as respiratory depression and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted interest in nerve blocking techniques for operative analgesia.

The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of the face through the foramen rotundum, and then passes forward and laterally through the pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of the orbit by the infra-orbital foramen. This sensory nerve supplies innervation of the lower eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate. Bilateral infra-orbital nerve block is clearly inefficient for anesthesia of the posterior part of the palate (hard palate). The infrazygomatic route of the maxillary block, useful for trigeminal neuralgia, can present several risks such as penetration of the orbit or the skull and accidental maxillary artery puncture. The palatine nerve block could be efficient for analgesia following cleft palate repair, but the technique requires identifying the first molar, which is absent in infants. Finally, submucosal infiltration performed by the surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic approach has demonstrated beneficial effects in adults for trigeminal neuralgia and limits the risks related to the procedure.

Eligibility criteria: Inclusion Criteria:

* Age between 1 and 9 years
* Children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts
* Gender: both
* ASA grade I - II.
* Informed consent.

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

Primary outcomes:
measure: Postoperative pain score
timeFrame: baseline
measure: Assessment of Behavioral Score
timeFrame: baseline
Secondary outcomes:
measure: The first-time requested analgesia .
timeFrame: 24 hours
measure: The number of children required analgesia.
timeFrame: 24 hours
measure: The total amount of analgesic requirements .
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References: