Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy
Primary Purpose
Postoperative Pain Management
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trans-cutaneous ultrasound guided peritonsillar infiltration
trans-oral ultrasound guided peritonsillar infiltration
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain Management
Eligibility 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.
Sites / Locations
- Al-Azhar University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
trans-cutaneous ultrasound guided peritonsillar infiltration
trans-oral ultrasound guided peritonsillar infiltration
Arm Description
Outcomes
Primary Outcome Measures
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).
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03361813
Brief Title
Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy
Official Title
Comparative Study Between Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Space Infiltration With Bupivacaine During Elective Tonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2017 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
trans-cutaneous ultrasound guided peritonsillar infiltration
Arm Type
Active Comparator
Arm Title
trans-oral ultrasound guided peritonsillar infiltration
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
trans-cutaneous ultrasound guided peritonsillar infiltration
Intervention Description
Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a transcutaneous route
Intervention Type
Other
Intervention Name(s)
trans-oral ultrasound guided peritonsillar infiltration
Intervention Description
Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a trans-oral route
Primary Outcome Measure Information:
Title
Surgical field (intra-operative reactionary bleeding and/or muscle tear)
Description
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 Frame
time of surgery
Title
Surgeon satisfaction
Description
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 Frame
time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Warda D K Ali, MD
Phone
01224668648
Ext
002
Email
warda2001@hotmail.com
Facility Information:
Facility Name
Al-Azhar University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warda DK Ali, MD
Phone
0122668648
Ext
002
Email
warda2001@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy
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