Suprazygomatic Maxillary Nerve Block Effect on Systemic Inflammatory Response in Cleft Palate Surgeries

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495750
• Other study ID #: FMASU MD 141/2022
• Status: Completed
• Phase: Phase 4
• Start date: June 24, 2022
• Est. completion date: February 25, 2024

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 25, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Perioperative Inflammatory Response
• Postoperative Pain

Intervention

Drug:
• Bupivacaine 0.25% Injectable Solution
ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg.

Locations

Country	Name	City	State
Egypt	Faculty of dentisry Ainshams univeristy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Mohamed Abdel Salam Ibrahim Soliman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin 6 serum level.	Two blood samples will be withdrawn in both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient	3-5 hours
Secondary	Serum Cortisol level	Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient	3-5 hours
Secondary	Plasma glucose level	Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient	3-5 hours
Secondary	C-Reactive protein (CRP)	Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient	3-5 hours
Secondary	Total leucocytic count	Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient	3-5 hours
Secondary	CHIPPS score	Score 0 , Score 1 , Score 2	1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h postoperatively.
Secondary	The number of rescue analgesia doses postoperatively	IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was > 3/10	12 hours postoperative
Secondary	time needed till the need of first dose recorded of rescue analgesia	IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was > 3/10	12 hours post operative
Secondary	Time needed to start oral feeding will be recorded	time of starting oral feeding	12 hours postoperative