Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics

March 26, 2020 updated by: Benjamin Javillier, University of Liege

Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of NaCl 0,9%, Xylocaine 2% or Levobupivacaine 0,5%

Check analgesia after tonsillectomy in adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We hypothesize that a vaporization of local anesthetics in the tonsil lodge would reduce postoperative pain.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Javillier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Tonsillectomy

Exclusion Criteria:

  • Gastric or duodenal ulcer
  • Diabetes
  • Kidney failure
  • Chronic pain and fibromyalgia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: NaCl 0,9%
patients receive 5ml of NaCl 0,9% at the level of the tonsils lodge
Drug: levobupivacaine
Patient satisfaction and pain score using a visual anagogic scale (VAS)
Other Names:
  • xylocaine
  • Nacl
Active Comparator: Xylocaine 2%
patients receive 5ml of Xylocaïne 2% at the level of the tonsils lodge
Drug: levobupivacaine
Patient satisfaction and pain score using a visual anagogic scale (VAS)
Other Names:
  • xylocaine
  • Nacl
Active Comparator: Levobupivacaine 0,5%
patients receive 5ml of Levobupivacaine 0,5% at the level of the tonsils lodge
Drug: levobupivacaine
Patient satisfaction and pain score using a visual anagogic scale (VAS)
Other Names:
  • xylocaine
  • Nacl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's satisfaction and pain score
Time Frame: until 10 days after the tonsillectomy.
patient satisfaction and pain score using a visual anagogic scale from 0 (no pain) to 10 (intolerable pain)
until 10 days after the tonsillectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tonsilstopic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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