TonsillectomyPhase 4NCT01582022
Evaluation of The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain
A Phase 4 study testing Bupivacaine and normal saline in people with Tonsillectomy, run by King Saud University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Bupivacaine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing tonsillectomy
Who cannot join
- pt with past history of unilateral peritonsillar abscess
- the current, regular use of a systemic steroid or NSAID
- a known hypersensitivity to bupivacaine
- a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
- pt with poor dental hygiene
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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 :
- pt with past history of unilateral peritonsillar abscess
- the current, regular use of a systemic steroid or NSAID
- a known hypersensitivity to bupivacaine
- a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
- 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.
- Conditions
- Tonsillectomy
- Being tested
- Bupivacaine, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called marcaine
local application for 5 minutes
normal salineDrug
Also called comparator
local application for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| local anesthetic | Experimental | local anesthetic agent Receives: Drug: Bupivacaine |
| normal saline | Placebo comparator | comparator Receives: Drug: normal saline |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulmalik S. Alsaied, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582022
- Sponsor's protocol ID
- E-12-598
- Status last verified
- Apr 2012
- First submitted
- 15 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain
- ClinicalTrials.gov ID
- NCT01582022
- Acronym / sponsor ID
- E-12-598
- Conditions
- Tonsillectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 :
- pt with past history of unilateral peritonsillar abscess
- the current, regular use of a systemic steroid or NSAID
- a known hypersensitivity to bupivacaine
- a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anesthetic | Experimental | Drug: Bupivacainelocal anesthetic agent |
| normal saline | Placebo comparator | Drug: normal salinecomparator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing tonsillectomy
Key exclusion criteria (5 listed)
- pt with past history of unilateral peritonsillar abscess
- the current, regular use of a systemic steroid or NSAID
- a known hypersensitivity to bupivacaine
- a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
- pt with poor dental hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: marcainelocal application for 5 minutes | Drug | local anesthetic |
| normal salineAlso: comparatorlocal application for 5 minutes | Drug | normal saline |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
Related trials for Tonsillectomy
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and normal saline in people with Tonsillectomy, run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdulmalik s alsaied, sborl (00966504808705, malik0099@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.