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

Primary Purpose

Perioperative Inflammatory Response, Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.25% Injectable Solution
Sponsored by
Alaa Mohamed Abdel Salam Ibrahim Soliman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Inflammatory Response

Eligibility Criteria

1 Year - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of dentisry Ainshams univeristyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Maxillary block group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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Two blood samples will be withdrawn in both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn after completion of surgery and before recovery of the patient

Secondary Outcome Measures

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Two blood samples will be withdrawn in the both groups, the first sample immediately after induction of general anaesthesia, endotracheal tube insertion and the other sample will be withdrawn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
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
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
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
CHIPPS score
Score 0 , Score 1 , Score 2
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
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
Time needed to start oral feeding will be recorded
time of starting oral feeding

Full Information

First Posted
August 9, 2022
Last Updated
August 9, 2022
Sponsor
Alaa Mohamed Abdel Salam Ibrahim Soliman
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1. Study Identification

Unique Protocol Identification Number
NCT05495750
Brief Title
Suprazygomatic Maxillary Nerve Block Effect on Systemic Inflammatory Response in Cleft Palate Surgeries
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Mohamed Abdel Salam Ibrahim Soliman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Inflammatory Response, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maxillary block group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will receive only general anesthesia with regulated doses of IV opioids.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Other Intervention Name(s)
supra zygomatic maxillary nerve block
Intervention Description
ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg.
Primary Outcome Measure Information:
Title
Interleukin 6 serum level.
Description
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
Time Frame
3-5 hours
Secondary Outcome Measure Information:
Title
Serum Cortisol level
Description
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
Time Frame
3-5 hours
Title
Plasma glucose level
Description
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
Time Frame
3-5 hours
Title
C-Reactive protein (CRP)
Description
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
Time Frame
3-5 hours
Title
Total leucocytic count
Description
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
Time Frame
3-5 hours
Title
CHIPPS score
Description
Score 0 , Score 1 , Score 2
Time Frame
1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h postoperatively.
Title
The number of rescue analgesia doses postoperatively
Description
IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was > 3/10
Time Frame
12 hours postoperative
Title
time needed till the need of first dose recorded of rescue analgesia
Description
IM Diclofenac(0.5 mg/kg) will be given as rescue analgesia for patients if CHIPPS was > 3/10
Time Frame
12 hours post operative
Title
Time needed to start oral feeding will be recorded
Description
time of starting oral feeding
Time Frame
12 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa M Soliman, MSc
Phone
00201128180083
Email
alaasoliman@dent.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Sohib M Galal, MD
Phone
00201006722112
Email
sohibgalal@dent.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif S Sultan, MD
Organizational Affiliation
Ainshams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tamer N Ibrahim AbdelRahman, MD
Organizational Affiliation
Ainshams Univeristy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sohib M Galal, MD
Organizational Affiliation
Ainshams Univeristy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarah A Salem, MD
Organizational Affiliation
Ainshams Univeristy
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of dentisry Ainshams univeristy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherif S Sultan, MD
Phone
00201128448448
Email
sherif_sultan@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Summary results
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Internet search by keywords

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

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