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

NCT ID: NCT05495750

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-24
• Study Completion Date: 2024-02-25

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.

Conditions

Perioperative Inflammatory Response; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine 0.25% Injectable Solution

Intervention Type: DRUG

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

Control group

Patients will receive only general anesthesia with regulated doses of IV opioids.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bupivacaine 0.25% Injectable Solution

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

Intervention Type: DRUG

Other Intervention Names

supra zygomatic maxillary nerve 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alaa Mohamed Abdel Salam Ibrahim Soliman

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mohamed Abdel Salam Ibrahim Soliman

Assistant Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sherif S Sultan, MD

Role: STUDY_DIRECTOR

Ainshams University

Tamer N Ibrahim AbdelRahman, MD

Role: STUDY_CHAIR

Ainshams Univeristy

Sohib M Galal, MD

Role: STUDY_CHAIR

Ainshams Univeristy

Sarah A Salem, MD

Role: STUDY_CHAIR

Ainshams Univeristy

Locations

Faculty of dentisry Ainshams univeristy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MD 141/2022

Identifier Type: -

Identifier Source: org_study_id