Peripheral Nerve Block Techniques During Cleft Palate

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: peripheral nerve block by 0.25% levobupivacaine

• Registration Number: NCT04467463
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-07-04
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-13
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Study Start: 2020-11-01
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GPN	peripheral nerve block by 0.25% levobupivacaine	administrated bilateral greater palatine nerve block using levobupivacaine 0.25%
SMN	peripheral nerve block by 0.25% levobupivacaine	administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.

Primary Outcome Measures

Name	Time	Method
postoperative pain score	the first 12 postoperative hours	Pain assessment was done immediately postoperative using Objective behavioral pain score

Trial Locations

Locations (2)

Cairo University hospitals; 🇪🇬 Cairo, Manial, Egypt

anesthesia department at Cairo University; 🇪🇬 Cairo, Egypt