Back to resultsPost Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics
Primary Purpose
Analgesia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
levobupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- Tonsillectomy
Exclusion Criteria:
- Gastric or duodenal ulcer
- Diabetes
- Kidney failure
- Chronic pain and fibromyalgia
Sites / Locations
- Javillier
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
NaCl 0,9%
Xylocaine 2%
Levobupivacaine 0,5%
Arm Description
patients receive 5ml of NaCl 0,9% at the level of the tonsils lodge
patients receive 5ml of Xylocaïne 2% at the level of the tonsils lodge
patients receive 5ml of Levobupivacaine 0,5% at the level of the tonsils lodge
Outcomes
Primary Outcome Measures
Patient's satisfaction and pain score
patient satisfaction and pain score using a visual anagogic scale from 0 (no pain) to 10 (intolerable pain)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04325113
Brief Title
Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics
Official Title
Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of NaCl 0,9%, Xylocaine 2% or Levobupivacaine 0,5%
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Check analgesia after tonsillectomy in adults
Detailed Description
We hypothesize that a vaporization of local anesthetics in the tonsil lodge would reduce postoperative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NaCl 0,9%
Arm Type
Placebo Comparator
Arm Description
patients receive 5ml of NaCl 0,9% at the level of the tonsils lodge
Arm Title
Xylocaine 2%
Arm Type
Active Comparator
Arm Description
patients receive 5ml of Xylocaïne 2% at the level of the tonsils lodge
Arm Title
Levobupivacaine 0,5%
Arm Type
Active Comparator
Arm Description
patients receive 5ml of Levobupivacaine 0,5% at the level of the tonsils lodge
Intervention Type
Drug
Intervention Name(s)
levobupivacaine
Other Intervention Name(s)
xylocaine, Nacl
Intervention Description
Patient satisfaction and pain score using a visual anagogic scale (VAS)
Primary Outcome Measure Information:
Title
Patient's satisfaction and pain score
Description
patient satisfaction and pain score using a visual anagogic scale from 0 (no pain) to 10 (intolerable pain)
Time Frame
until 10 days after the tonsillectomy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tonsillectomy
Exclusion Criteria:
Gastric or duodenal ulcer
Diabetes
Kidney failure
Chronic pain and fibromyalgia
Facility Information:
Facility Name
Javillier
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics
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