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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltration | Experimental | Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. |
|
| Placebo | Placebo Comparator | Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infiltration | Other | 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% |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PONV | Post operative nausea and vomiting (PONV) will be assessed through a questionnaire | within 10 days after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoher Naja | Makassed General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makassed General Hospital | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Placebo | Other | Patients will receive 2.5 ml normal saline in each tonsil |
|
| General anesthesia | Other | All patients will receive general anesthesia prior to infiltration |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |