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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by King Saud University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Abdulmalik S. Alsaied, King Saud University
ClinicalTrials.gov Identifier:
NCT01582022
First received: April 15, 2012
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Tonsillectomy
Drug: Bupivacaine
Drug: normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain

Resource links provided by NLM:


Further study details as provided by King Saud University:

Arms Assigned Interventions
Experimental: local anesthetic
local anesthetic agent
Drug: Bupivacaine
local application for 5 minutes
Other Name: marcaine
Placebo Comparator: normal saline
comparator
Drug: normal saline
local application for 5 minutes
Other Name: comparator

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582022

Contacts
Contact: abdulmalik s alsaied, sborl 00966504808705 malik0099@hotmail.com

Sponsors and Collaborators
King Saud University
  More Information

No publications provided

Responsible Party: Abdulmalik S. Alsaied, otolaryngology specialist, King Saud University
ClinicalTrials.gov Identifier: NCT01582022     History of Changes
Other Study ID Numbers: E-12-598
Study First Received: April 15, 2012
Last Updated: April 19, 2012
Health Authority: Saudi Arabia: Ministry for Higher Education

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014