The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

Study Overview
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Brief Summary
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Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.

Detailed Description
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The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.

Official Title
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The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial

Conditions
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Post Operative Pain

Intervention / Treatment
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* Other: Infiltration
* Other: Placebo
* Other: General anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with total or partial tonsillectomy with or without adenoidectomy Exclusion Criteria: patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma patients who have diabetes patients who have bleeding problems patients who are suspected to have signs of acute pharyngeal infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infiltration<br>Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. | Other: Infiltration<br>* The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%<br>Other: General anesthesia<br>* All patients will receive general anesthesia prior to infiltration<br>|
| Placebo Comparator: Placebo<br>Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil. | Other: Placebo<br>* Patients will receive 2.5 ml normal saline in each tonsil<br>Other: General anesthesia<br>* All patients will receive general anesthesia prior to infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10. | within 10 days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV | Post operative nausea and vomiting (PONV) will be assessed through a questionnaire | within 10 days after the operation |