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

NCT03361813 | Unknown

• 1 other identifier: 201617019.2P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (2)

• Surgical field (intra-operative reactionary bleeding and/or muscle tear)

  * Iintra-operative reactionary bleeding and/or muscle tear assessment by number of soaked gauze per 20 min (per tonsil) (3 soaked gauze per 20 min (per tonsil) = no reactionary bleeding (0 point), 6 soaked gauze per 20 min (per tonsil) = mild bleeding (1 point) and 10 soaked gauze or more per 20 min (per tonsil) = moderate to severe bleeding (2 points). * Dissection time assessment (dissection time 10 min or less per tonsil = no bleeding (0 point), dissection time 20 min per tonsil = mild bleeding (1 point) and dissection time 30 min or more per tonsil = moderate to severe bleeding (2 points).

  time of surgery

• Surgeon satisfaction

  Direct surgeon questionnaire assessment about bleeding and surgical field (full satisfaction= no bleeding (0 point), fair satisfaction= mild bleeding (1point), and poor satisfaction= moderate to severe bleeding (2 points)

  time of surgery

Study Arms (2)

trans-cutaneous ultrasound guided peritonsillar infiltration

ACTIVE COMPARATOR

Other: trans-oral ultrasound guided peritonsillar infiltration

trans-oral ultrasound guided peritonsillar infiltration

PLACEBO COMPARATOR

Other: trans-cutaneous ultrasound guided peritonsillar infiltration

Interventions

trans-cutaneous ultrasound guided peritonsillar infiltration OTHER

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

trans-oral ultrasound guided peritonsillar infiltration

trans-oral ultrasound guided peritonsillar infiltration OTHER

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

trans-cutaneous ultrasound guided peritonsillar infiltration

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infection at the site of injection, peritonsillar abscess or cellulites.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Al-Azhar University Hospital

Cairo, Egypt

RECRUITING

Central Study Contacts

Warda D K Ali, MD

CONTACT

01224668648; warda2001@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor of Anesthesia ICU and pain Relief

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: December 5, 2017
• Study Start: December 10, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

EG (1)