Peripheral Nerve Block Techniques During Cleft Palate

NCT04467463 | Unknown

• 1 other identifier: N-98-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Suprazygomatic; Maxillary; Palatine; Cleft Palate

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  Pain assessment was done immediately postoperative using Objective behavioral pain score

  the first 12 postoperative hours

Study Arms (2)

GPN

EXPERIMENTAL

administrated bilateral greater palatine nerve block using levobupivacaine 0.25%

Procedure: peripheral nerve block by 0.25% levobupivacaine

SMN

EXPERIMENTAL

administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.

Procedure: peripheral nerve block by 0.25% levobupivacaine

Interventions

peripheral nerve block by 0.25% levobupivacaine PROCEDURE

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.

GPN; SMN

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I-III scheduled to undergo palatoplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo University hospitals

Cairo, Manial, 12511, Egypt

RECRUITING

anesthesia department at Cairo University

Cairo, Egypt

COMPLETED

Related Publications (4)

• Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.

  PMID: 460932 BACKGROUND

• 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. doi: 10.1001/jama.294.8.947.

  PMID: 16118385 BACKGROUND

• 3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.

  BACKGROUND

• Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1.

  PMID: 3860013 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Cleft Palate

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Sherif Abdullah Mohamed, M.D.

CONTACT

+201002013497; dr.sherif213@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: masking from the aim of the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The two study groups were: * Group GPN, 20 patients received bilateral greater palatine nerve block. * Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 13, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)