The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain
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.
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 :
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.
Inclusion Criteria:
Exclusion Criteria:
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