The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

January 14, 2022 updated by: Zoher Naja, Makassed General Hospital

The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Lebanon
      • Beirut, Lebanon
        • Makassed General Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infiltration
Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
Other: Infiltration
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%
Other: General anesthesia
All patients will receive general anesthesia prior to infiltration
Placebo Comparator: Placebo
Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.
Other: General anesthesia
All patients will receive general anesthesia prior to infiltration
Other: Placebo
Patients will receive 2.5 ml normal saline in each tonsil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: within 10 days after the operation
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.
within 10 days after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PONV
Time Frame: within 10 days after the operation
Post operative nausea and vomiting (PONV) will be assessed through a questionnaire
within 10 days after the operation

Collaborators and Investigators

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

Sponsor

Makassed General Hospital

Investigators

  • Principal Investigator: Zoher Naja, Makassed General Hospital

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)

January 7, 2019

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32015

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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