Glossopharyngeal Nerve Block on Post Tonsillectomy Pain A... | NCT05109416

Studies
Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

NCT05109416

Sponsor

Minia University

Status

Completed

Last Update Posted

Apr 22, 2022Actual

Enrollment

210Actual

Phase

Phase 1Phase 2

Conditions

Post Tonsillectomy Pain

Interventions

Bupivacaine Hydrochloride 0.5% Injection Solution
Saline 0.9%

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2021Actual

Primary Completion Date

Mar 5, 2022Actual

Completion Date

Mar 22, 2022Actual

First Submitted Date

Oct 29, 2021

First Submission Date that Met QC Criteria

Oct 29, 2021

First Posted Date

Nov 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Tonsillectomy is one of most common performed surgical procedure in children . tonsillectomy or adenotonsillectomy have high incidence of Post operative pain , it is very important and significant problem because it can lead to decrease oral intake and dehydration

Detailed Description

Tonsillectomy is one of the most common performed surgical procedure in children. Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence . There is still debate about the optimal analgesia for this common procedure , different methods have been described including intraoperative anesthetic pain regimens , adjustment of surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy post operative .

The main goal of the preventive analgesia is the pain releif with minimum side effect . The objective of this study is to investigate and compare the effect of Glossopharyngeal nerve block for relief of pain on children following adenotonsillectomy .

This is prospective , double blinded , randomized study

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Children will receive bupivacaine 0.5% ( 1 mg / kg ) ,divided in each side , by infiltration through anterior and posterior approaches to block glossopharyngeal nerve	Drug: Bupivacaine Hydrochloride 0.5% Injection Solution
Group B	Placebo Comparator	Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches	Drug: Saline 0.9%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine Hydrochloride 0.5% Injection Solution	Drug	Local anesthetic	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The first call for analgesia	Pain assessment using VAS scale	In 24 hours

Secondary Outcomes

Measure	Description	Time Frame
The analgesic consumption	The total analgesic consumption for pain rest and swallowing	In 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

average weight is 10_50 kg
patient is generally stable
indication of tonsillectomy is recurrent tonsillitis
Ability to self report pain

Exclusion Criteria:

Hypersensitivity to bupivacaine
Obstructive sleep apnea syndrome
Pulmonary or cardic diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medcine		Minya		61111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided