Peripheral Nerve Block Techniques During Cleft Palate

Comparing Two Peripheral Nerve Block Techniques for Perioperative Analgesia During Cleft Palate Surgery in Pediatric Patients: Randomized Controlled Trial

Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: peripheral nerve block by 0.25% levobupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherif Abdullah Mohamed, M.D.; Phone Number: 02 +201002013497; Email: dr.sherif213@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Completed
    • anesthesia department at Cairo University
  • Manial
    • Cairo, Manial, Egypt, 12511
      • Recruiting
      • Cairo University Hospitals
      • Contact: Ayman Hussam, M.D.; Phone Number: 01004389020; Email: Ahhussam@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-III scheduled to undergo palatoplasty

Exclusion Criteria:

• bleeding disorders,
• skin lesions or wounds at site of proposed needle insertion,
• congenital heart disease,
• respiratory or
• cardiovascular disorders,
• children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting,
• known hypersensitivity to local anesthetics or opioids and
• lack of parental consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GPN; administrated bilateral greater palatine nerve block using levobupivacaine 0.25%	Procedure: peripheral nerve block by 0.25% levobupivacaine; SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.
Experimental: SMN; administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.	Procedure: peripheral nerve block by 0.25% levobupivacaine; SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain score	Pain assessment was done immediately postoperative using Objective behavioral pain score	the first 12 postoperative hours

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249.
• Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. Review.
• 3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
• Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 4, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Cleft Palate; Suprazygomatic; Maxillary; Palatine
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: N-98-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: not to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No