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Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy

NCT ID: NCT03361813

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-10

Study Completion Date

2018-02-28

Brief Summary

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Ultrasound as a technique is safe, readily available, quick and portable allowing more accuracy of different regional blocks and local infiltration. It allows imaging of the mouth, oropharynx, infrahyoid structures, larynx, vocal cords, and trachea. Recently, ultrasound has been shown to improve accuracy in ultrasound guided block with local anesthetic infiltration. The objective of our study is to compare the effect of pre-emptive trans-oral ultrasound guided peritonsillar infiltration versus trans-cutaneous ultrasound (US) guided peritonsillar infiltration with bupivacaine for post-tonsillectomy analgesia, on surgical field, and surgeon satisfaction(intra-operative reactionary bleeding).

Materials and Methods: the patients will be admitted for tonsillectomy at ENT department of the Al- Azhar university hospitals. The patients' ages between 3 to 15 years. Patients will be divided into Cutaneous group: patients will be submitted to Trans-cutaneous ultrasound guided peritonsillar infiltration with bupivacaine, and Oral group: patients will be submitted to Trans-oral ultrasound guided peritonsillar infiltration with bupivacaine.

Detailed Description

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Conditions

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Postoperative Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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trans-cutaneous ultrasound guided peritonsillar infiltration

Group Type ACTIVE_COMPARATOR

trans-oral ultrasound guided peritonsillar infiltration

Intervention Type OTHER

Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a trans-oral route

trans-oral ultrasound guided peritonsillar infiltration

Group Type PLACEBO_COMPARATOR

trans-cutaneous ultrasound guided peritonsillar infiltration

Intervention Type OTHER

Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a transcutaneous route

Interventions

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trans-cutaneous ultrasound guided peritonsillar infiltration

Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a transcutaneous route

Intervention Type OTHER

trans-oral ultrasound guided peritonsillar infiltration

Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a trans-oral route

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA (American Society of Anesthesiologists) physical status I-II with no airway complications or systemic diseases or known psychological diseases. Reason for their surgery was recurrent or chronic tonsillitis.

Exclusion Criteria

* Infection at the site of injection, peritonsillar abscess or cellulites.
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Warda D K Ali, MD

Role: CONTACT

Phone: 01224668648

Email: [email protected]

Facility Contacts

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Warda DK Ali, MD

Role: primary

Other Identifiers

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201617019.2P

Identifier Type: -

Identifier Source: org_study_id