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NCT Number: NCT05495750

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

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.

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Key information

Conditions

Perioperative Inflammatory Response Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentisry Ainshams univeristy

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine 0.25% Injectable Solution

Drug

ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg.

Other names: supra zygomatic maxillary nerve block

Primary outcomes

  1. Interleukin 6 serum level.

    Time frame: 3-5 hours

    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

Secondary outcomes

  1. Serum Cortisol level

    Time frame: 3-5 hours

    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

  2. Plasma glucose level

    Time frame: 3-5 hours

    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. C-Reactive protein (CRP)

    Time frame: 3-5 hours

    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

  4. Total leucocytic count

    Time frame: 3-5 hours

    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

  5. CHIPPS score

    Time frame: 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h postoperatively.

    Score 0 , Score 1 , Score 2

  6. The number of rescue analgesia doses postoperatively

    Time frame: 12 hours postoperative

    IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was > 3/10

  7. time needed till the need of first dose recorded of rescue analgesia

    Time frame: 12 hours post operative

    IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was > 3/10

  8. Time needed to start oral feeding will be recorded

    Time frame: 12 hours postoperative

    time of starting oral feeding

Sponsors and collaborators

Lead sponsor

Alaa Mohamed Abdel Salam Ibrahim Soliman

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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