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Peripheral Nerve Block Techniques During Cleft Palate

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

peripheral nerve block by 0.25% levobupivacaine

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Suprazygomatic, Maxillary, Palatine, Cleft Palate

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cairo University hospitalsRecruiting
anesthesia department at Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GPN

SMN

Arm Description

administrated bilateral greater palatine nerve block using levobupivacaine 0.25%

administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.

Outcomes

Primary Outcome Measures

postoperative pain score

Pain assessment was done immediately postoperative using Objective behavioral pain score

Secondary Outcome Measures

Full Information

NCT ID

NCT04467463

First Posted

July 4, 2020

Last Updated

October 27, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04467463

Brief Title

Peripheral Nerve Block Techniques During Cleft Palate

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Suprazygomatic, Maxillary, Palatine, Cleft Palate

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

Care Provider

Masking Description

masking from the aim of the study

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GPN

Arm Type

Experimental

Arm Description

administrated bilateral greater palatine nerve block using levobupivacaine 0.25%

Arm Title

SMN

Arm Type

Experimental

Arm Description

administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.

Intervention Type

Procedure

Intervention Name(s)

peripheral nerve block by 0.25% levobupivacaine

Intervention Description

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.

Primary Outcome Measure Information:

Title

postoperative pain score

Description

Pain assessment was done immediately postoperative using Objective behavioral pain score

Time Frame

the first 12 postoperative hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherif Abdullah Mohamed, M.D.

Phone

+201002013497

Ext

dr.sherif213@yahoo.com

Facility Information:

Facility Name

Cairo University hospitals

City

Cairo

State/Province

Manial

ZIP/Postal Code

12511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayman Hussam, M.D.

Phone

01004389020

Ahhussam@yahoo.com

Facility Name

anesthesia department at Cairo University

City

Cairo

Country

Egypt

Individual Site Status

Completed

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

not to share

Citations:

PubMed Identifier

460932

Citation

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.

Results Reference

background

PubMed Identifier

16118385

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. doi: 10.1001/jama.294.8.947.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

3860013

Citation

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.

Results Reference

background

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Peripheral Nerve Block Techniques During Cleft Palate

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