Suprazygomatic Nerve Block in Tonsillectomy Patients

NCT06359925 | Not Yet Recruiting

• 1 other identifier: Suprazygomatic nerve block
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids.

Conditions

Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score

  Postoperative pain will be recorded using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores at admission to the PACU \[0\] minutes (baseline), \[30 \]minutes, \[1\], \[4\], \[8\],\[ 12\], \[18\] and \[24\] hours postoperatively. where the minimum score of zero (no pain) and the maximum score of 12 (the most severe pain). Children with the modified CHEOPS \[ ≥ 5 \]will be given supplemental analgesia with IV paracetamol 15 mg/kg , Pain scores will be recorded 15-20 minutes following the administration of this supplemental analgesia to assess pain relief. The number of children that required postoperative rescue analgesics, the first time to rescue analgesia, and the total amount of rescue analgesia consumed within \[24\] hours postoperatively will be recorded.

  24 hours

Secondary Outcomes (2)

• time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale

  24 hours

• Parents satisfaction score

  24 hours

Study Arms (2)

Group S

ACTIVE COMPARATOR

Suprazygomatic maxillary nerve block using Dexmedetomidine Plus Bupivacaine

Procedure: Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine

Group c( control)

PLACEBO COMPARATOR

Suprazygomatic maxillary nerve block using Bupivacaine only

Procedure: Suprazygomatic maxillary nerve block using Bupivacaine

Interventions

Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine PROCEDURE

After induction of general anaesthesia blockade of the contents of the pterygopalatine fossa is performed bilaterally before starting surgery as follows: After complete aseptic skin preparation and under ultrasound guidance images are obtained with a high-frequency linear array probe. The ultrasound transducer is placed in the infrazygomatic area, over the maxilla, angled \[45 \]degree cephalad. This probe position allows visualization of the pterygopalatine fossa,The needle is advanced using an out-of-plane approach, and the needle tip can usually be identified during movements. the injectate consisted of \[4\]mL of \[0.5% \]Bupivacaine combined with \[1\]mL of\[ 5\]µg dexmedetomidine. The injectate is delivered over \[15-20 \] seconds, while observing the spread of the local anesthetic under ultrasoundThe same procedure is then repeated on the contralateral side.

Group S

Suprazygomatic maxillary nerve block using Bupivacaine PROCEDURE

After induction of general anaesthesia blockade of the contents of the pterygopalatine fossa is performed bilaterally before starting surgery as follows: After complete aseptic skin preparation and under ultrasound guidance images are obtained with a high-frequency linear array probe. The ultrasound transducer is placed in the infrazygomatic area, over the maxilla, angled \[45 \]degree cephalad. This probe position allows visualization of the pterygopalatine fossa,The needle is advanced using an out-of-plane approach, and the needle tip can usually be identified during movements. the injectate consisted of \[4\]mL of \[0.5% \]Bupivacaine combined with \[1\]mL normal saline . The injectate is delivered over \[15-20 \] seconds, while observing the spread of the local anesthetic under ultrasoundThe same procedure is then repeated on the contralateral side.

Group c( control)

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-10 years old
• The American Society of Anesthesiologists (ASA) I and II
• Children scheduled for tonsillectomy with or without adenoidectomy.

You may not qualify if:

• Patient's guardian refusal to participate in the study.
• Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
• Children on sedative or anticonvulsant medication.
• Bleeding diathesis
• History of sleep apnea
• Significant organ dysfunction.
• cardiac dysrhythmia.
• congenital heart disease .
• Known allergy to the study drugs.
• Skin lesions or wounds at the puncture site of the proposed block

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ahmed Asaad

CONTACT

01147322947; asaadahmed2521997@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 11, 2024
• Study Start: October 22, 2024
• Primary Completion: September 20, 2025
• Study Completion: February 20, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04