Peripheral Nerve Block Techniques During Cleft Palate

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467463
• Other study ID #: N-98-2019
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: Sherif Abdullah Mohamed, M.D.
• Phone: +201002013497
• Email: dr.sherif213[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Egypt	anesthesia department at Cairo University	Cairo
Egypt	Cairo University hospitals	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score	Pain assessment was done immediately postoperative using Objective behavioral pain score	the first 12 postoperative hours