Clinical trial NCT05495750: Suprazygomatic Maxillary Nerve Block Effect on Systemic Inflammatory Response in Cleft Palate Surgeries
Official title: The Impact of Adding Ultrasound Guided Bilateral Suprazygomatic Maxillary Nerve Block to General Anesthesia on Systemic Inflammatory Response in Cleft Palate Surgeries ; A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perioperative Inflammatory Response
Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the aim is to determine the value of adding bilateral supra zygomatic maxillary nerve block to general anesthesia in attenuating the systemic inflammatory response in paediatrics.

Detailed description: Cleft lip and palate are some of the most common craniofacial malformations, with an incidence ranging between 0.1 and 1.1 per 1000 births. Early surgical intervention for cleft palate (CP) repair is essential for proper feeding and phonation as well as reduction of complications such as frequent sinusitis and other respiratory tract infections.

Surgical injury stimulates the systemic inflammatory response. The neuroendocrine response leads to stimulation of the sympathetic nervous system resulting in tachycardia, hypertension and activation of the hypothalamic-pituitary adrenal axis. This induces the release of hormones such as adrenocorticotropic hormone (ACTH), catechol-amines (norepinephrine and epinephrine) and cortisol and increase in white cell count which is proposed to have a detrimental effect on the postoperative immunity. Furthermore, the production of pro-inflammatory cytokines including interleukins (IL) e.g.IL-1, IL-6, IL-8 and tumour necrosis factor alpha (TNF-α) by innate immune cells such as neutrophils and macrophages, interacting with damaged cells and platelets, leads to the production of acute phase proteins from the liver such as C-reactive protein (CRP), fibrinogen and complement proteins.

Regional blocks provide good pre-emptive analgesia when given in combination with general anaesthesia (GA). It is associated with hemodynamic stability, rapid recovery, reduction of supplemental analgesia consumption in addition to favourable effect on systematic inflammatory response. Using bilateral suprazygomatic approach of maxillary nerve block during CP repair is hypothesized to provide such mentioned settlement of a regional block.

Eligibility criteria: Inclusion Criteria:

* Primary and secondary cleft palate Surgeries.
* American Society of Anesthesiologists physical status (ASA) I to II patients.
* Age group: 1-5 years old.

Exclusion Criteria:

* Presence of coagulation disorders.
* Peripheral neuropathy.
* Local infection or lesion in puncture site.
* Allergy to local Anesthetics.
* Physical status: ASA III or above.

Primary outcomes:
measure: Interleukin 6 serum level.
timeFrame: 3-5 hours
Secondary outcomes:
measure: Serum Cortisol level
timeFrame: 3-5 hours
measure: Plasma glucose level
timeFrame: 3-5 hours
measure: C-Reactive protein (CRP)
timeFrame: 3-5 hours
measure: Total leucocytic count
timeFrame: 3-5 hours
measure: CHIPPS score
timeFrame: 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h postoperatively.
measure: The number of rescue analgesia doses postoperatively
timeFrame: 12 hours postoperative
measure: time needed till the need of first dose recorded of rescue analgesia
timeFrame: 12 hours post operative
measure: Time needed to start oral feeding will be recorded
timeFrame: 12 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentisry Ainshams univeristy
Study officials:
affiliation: Ainshams University
name: Sherif S Sultan, MD
role: STUDY_DIRECTOR
affiliation: Ainshams Univeristy
name: Tamer N Ibrahim AbdelRahman, MD
role: STUDY_CHAIR
affiliation: Ainshams Univeristy
name: Sohib M Galal, MD
role: STUDY_CHAIR
affiliation: Ainshams Univeristy
name: Sarah A Salem, MD
role: STUDY_CHAIR
References: