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

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ClinicalTrials.gov Identifier: NCT03361813
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed H Othman, Assiut University

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Management Other: trans-cutaneous ultrasound guided peritonsillar infiltration Other: trans-oral ultrasound guided peritonsillar infiltration Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparative Study Between Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Space Infiltration With Bupivacaine During Elective Tonsillectomy
Actual Study Start Date : December 10, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: trans-cutaneous ultrasound guided peritonsillar infiltration Other: trans-oral ultrasound guided peritonsillar infiltration
Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a trans-oral route

Placebo Comparator: trans-oral ultrasound guided peritonsillar infiltration Other: trans-cutaneous ultrasound guided peritonsillar infiltration
Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a transcutaneous route




Primary Outcome Measures :
  1. Surgical field (intra-operative reactionary bleeding and/or muscle tear) [ Time Frame: time of surgery ]
    • 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).

  2. Surgeon satisfaction [ Time Frame: time of surgery ]
    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)



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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361813


Contacts
Contact: Warda D K Ali, MD 01224668648 ext 002 warda2001@hotmail.com

Locations
Egypt
Al-Azhar University Hospital Recruiting
Cairo, Egypt
Contact: Warda DK Ali, MD    0122668648 ext 002    warda2001@hotmail.com   
Sponsors and Collaborators
Assiut University

Responsible Party: Ahmed H Othman, Assisstant professor of Anesthesia ICU and pain Relief, Assiut University
ClinicalTrials.gov Identifier: NCT03361813     History of Changes
Other Study ID Numbers: 201617019.2P
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents