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

Tonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01582022
• Other study ID #: E-12-598
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 15, 2012
• Last updated: April 19, 2012

Study information

• Verified date: April 2012
• Source: King Saud University
• Contact: abdulmalik s alsaied, sborl
• Phone: 00966504808705
• Email: malik0099[@]hotmail.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

Drug:
• Bupivacaine
local application for 5 minutes
• normal saline
local application for 5 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University