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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Perioperative Inflammatory Response
• Intervention / Treatment: Drug: Bupivacaine 0.25% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of dentisry Ainshams univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Maxillary block group; The ultrasound probe will be placed in the infra zygomatic area, with an inclination of 45 degrees in the transverse plane. A 27-gauge 38-mm needle will be used for the injection. The needle will be inserted perpendicular to the skin at the frontozygomatic angle and advanced to the greater wing of the sphenoid. The needle will be then redirected and advanced to the pterygopalatine fossa. Loss of resistance after passing through the temporalis muscle will assist in determining the puncture depth, and real-time ultrasound guidance will allow seeing the spread of local anesthetic in the pterygopalatine fossa.	Drug: Bupivacaine 0.25% Injectable Solution; ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg.; Other Names: supra zygomatic maxillary nerve block
No Intervention: Control group; Patients will receive only general anesthesia with regulated doses of IV opioids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
CHIPPS score	Score 0 , Score 1 , Score 2	1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h postoperatively.
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
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
Time needed to start oral feeding will be recorded	time of starting oral feeding	12 hours postoperative

Collaborators and Investigators

• Sponsor: Alaa Mohamed Abdel Salam Ibrahim Soliman
• Investigators: Study Director: Sherif S Sultan, MD, AinShams University; Study Chair: Tamer N Ibrahim AbdelRahman, MD, Ainshams Univeristy; Study Chair: Sohib M Galal, MD, Ainshams Univeristy; Study Chair: Sarah A Salem, MD, Ainshams Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): February 25, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: FMASU MD 141/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Summary results
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Internet search by keywords
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No