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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04467463
Enrollment
40
Registered
2020-07-13
Start date
2020-11-01
Completion date
2020-12-31
Last updated
2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Suprazygomatic, Maxillary, Palatine, Cleft Palate

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.

Interventions

PROCEDUREperipheral 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Masking description

masking from the aim of the study

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain scorethe first 12 postoperative hoursPain assessment was done immediately postoperative using Objective behavioral pain score

Countries

Egypt

Contacts

Primary ContactSherif Abdullah Mohamed, M.D.
dr.sherif213@yahoo.com+201002013497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026