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The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

Primary Purpose

Post Operative Pain

Status
Suspended
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Infiltration
Placebo
General anesthesia
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with total or partial tonsillectomy with or without adenoidectomy

Exclusion Criteria:

  • patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma
  • patients who have diabetes
  • patients who have bleeding problems
  • patients who are suspected to have signs of acute pharyngeal infection

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Infiltration

Placebo

Arm Description

Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.

Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.

Outcomes

Primary Outcome Measures

Post operative pain
Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.

Secondary Outcome Measures

PONV
Post operative nausea and vomiting (PONV) will be assessed through a questionnaire

Full Information

First Posted
January 14, 2019
Last Updated
January 14, 2022
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03806335
Brief Title
The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy
Official Title
The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
Lack of patients
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

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
Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.
Detailed Description
The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infiltration
Arm Type
Experimental
Arm Description
Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.
Intervention Type
Other
Intervention Name(s)
Infiltration
Intervention Description
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will receive 2.5 ml normal saline in each tonsil
Intervention Type
Other
Intervention Name(s)
General anesthesia
Intervention Description
All patients will receive general anesthesia prior to infiltration
Primary Outcome Measure Information:
Title
Post operative pain
Description
Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.
Time Frame
within 10 days after the operation
Secondary Outcome Measure Information:
Title
PONV
Description
Post operative nausea and vomiting (PONV) will be assessed through a questionnaire
Time Frame
within 10 days after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with total or partial tonsillectomy with or without adenoidectomy Exclusion Criteria: patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma patients who have diabetes patients who have bleeding problems patients who are suspected to have signs of acute pharyngeal infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

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