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

NCT05495750 | Completed Phase 4

• 1 other identifier: FMASU MD 141/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Inflammatory Response; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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  Two blood samples will be withdrawn in both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient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 Outcomes (8)

• Serum Cortisol level

  3-5 hours

• Plasma glucose level

  3-5 hours

• C-Reactive protein (CRP)

  3-5 hours

• Total leucocytic count

  3-5 hours

• CHIPPS score

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

Study Arms (2)

Maxillary block group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Bupivacaine 0.25% Injectable Solution DRUG

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

Also known as: supra zygomatic maxillary nerve block

Maxillary block group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alaa Mohamed Abdel Salam Ibrahim Soliman: lead

Study Sites (1)

Faculty of dentisry Ainshams univeristy

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sherif S Sultan, MD

  Ainshams University

  STUDY DIRECTOR

• Tamer N Ibrahim AbdelRahman, MD

  Ainshams Univeristy

  STUDY CHAIR

• Sohib M Galal, MD

  Ainshams Univeristy

  STUDY CHAIR

• Sarah A Salem, MD

  Ainshams Univeristy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: June 24, 2022
• Primary Completion: January 5, 2024
• Study Completion: February 25, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: Internet search by keywords

Locations

EG (1)