Evaluation of The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain

April 19, 2012 updated by: Abdulmalik S. Alsaied, King Saud University

The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain

Research Methodology:

It will be a prospective, randomized, placebo-controlled, single-blind, intra-individual study in which one tonsillar fossa will be the tested side, and the other fossa will be the control. And the tested side will be packed with bupivacaine for five minutes. In the other hand, the controlled side will be packed for five minutes with gauze soaked in normal saline. The selection of the tested side and controlled side will be randomized based on the last digit in the medical record number (i.e. if the last digit is even then the tested side is the right and if the last digit is odd then the tested side is the left). Pain evaluation will be by visual analog scale and it will be in frequency of 2, 4, 6, 8, 12, 24 hours post-op.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Evaluation of The Effect of Bupivacaine (marcaine) in Reducing Early Post Tonsillectomy Pain (Prospective, randomized, intra-individual study.) Study guidelines

Aim of the study

- to evaluate the effectiveness of applying bupivacaine intra-operative in reducing early post-tonsillectomy pain

Patients and methods

  • It will be a randomized, placebo-controlled, single-blinded study
  • one tonsillar fossa will be the tested side, and the other fossa will be the control
  • to insure the random selection, the tested and control sides will be selected based on unpredicted method e.g. based on the last number in pt MRN: If the last # is even (0, 2, 4, 6, 8) = right side will be the tested If the last # is odd (1, 3, 5, 7, 9) = left side will be the tested

  • Exclusion criteria included :

    1. pt with past history of unilateral peritonsillar abscess
    2. the current, regular use of a systemic steroid or NSAID
    3. a known hypersensitivity to bupivacaine
    4. a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
    5. pt with poor dental hygiene
  • accompanied adenoidectomy is not an exclusion criteria
  • the tested side will be : packed (after classic tonsillectomy) with gauze soaked in 0.5% bupivacaine, (2ml of bupivacaine + 2ml NS)for 5 min.
  • the control side will undergoing the same of tested side but with normal saline
  • post-operative analgesia will be paracetamol
  • pain evaluation will be by visual analog scale (fig. 1) and it will be in frequency of 2, 4, 6, 8, 12, 24 hours post-op (frequency can be re-adjusted)
  • Data of pain will be collected by the nurse. And they will not know which side is the tested. (single- blind)
  • after phase I (data collection). Data will be calculated for P-value and other statistics scores
  • Targeted sample size is 35 patients.
  • patients will be consented for the possible adverse reactions of local application of the tested medicine (e.g. allergic reactions, Paresthesia). However, because in our study we will not add adrenaline, so differences in incidence of post-tonsillectomy bleeding is not expected.
  • data will be statistically analyzed by McNemar's test
  • For the data safety monitoring of the study, an independent external otolaryngology consultant (Dr.Ahmed Alarfij) will be assigned to monitor the safety of study participants.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients undergoing tonsillectomy

Exclusion Criteria:

  1. pt with past history of unilateral peritonsillar abscess
  2. the current, regular use of a systemic steroid or NSAID
  3. a known hypersensitivity to bupivacaine
  4. a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
  5. pt with poor dental hygiene

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: Supportive Care
  • Allocation: Randomized
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: local anesthetic
local anesthetic agent
Drug: Bupivacaine
local application for 5 minutes
Other Names:
  • marcaine
Placebo Comparator: normal saline
comparator
Drug: normal saline
local application for 5 minutes
Other Names:
  • comparator

Collaborators and Investigators

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

Sponsor

King Saud University

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 Registration Dates

First Submitted

April 15, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-12-598

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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