Effect of Ketamine Addition to Lidocaine in Rhinoplasty

Study Overview
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Brief Summary
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The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.

Detailed Description
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In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.

Official Title
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Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty

Conditions
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Nose Deformities, Acquired

Intervention / Treatment
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* Drug: Lidocaine 2 %
* Drug: Ketamine plus Lidocaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective rhinoplasty operation under general anesthesia Patients with ASA (American Society of Anesthesiology) class I Patients between 18-50 years old Exclusion Criteria: Age <18 and >50 ASA > II Preexisting neurological or psychiatric illness Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...) Having a history of chronic pain and receiving chronic analgesia therapy Having a history of drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group L (number of participants=30)<br>After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity. | Drug: Lidocaine 2 %<br>* 12 mL lidocaine 2% 1mg/kg<br>* Other names: preincisional infiltration of lidocaine;|
| Active Comparator: Group K (number of participants=30)<br>After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL ketamine 0.5 mg/kg plus lidocaine 2% 1 mg/kg of the intranasal cavity. | Drug: Ketamine plus Lidocaine<br>* ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL<br>* Other names: preincisional infiltration of ketamine plus lidocaine;|
| Placebo Comparator: Group S (number of participants=30)<br>After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity. | Drug: Saline<br>* 12 mL saline (0.9% isotonic solution)<br>* Other names: preincisional infiltration of saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores on the Visual Analogue Scale | Pain scores will examine with Visual analogue scale (VAS, 0-100) in the first 24 hours of postoperative period. The examination will repeated in different time period(5.min, 15.min, 30.min, 1 h, 2h,4.h, 6.h, 8.h, 16.h, 24.h). Patients that have VAS>40 will receive 1mg/kg tramadol. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | At the end of postoperative 24 h, the patient satisfaction will examine by a score as (1 poor, 2 middle, 3 good, 4 perfect) | 24 hour | 
| Analgesic demand | At the first day of postoperative period, analgesic requirement will record. When Visual analogue scale > 40, intravenous 1 mg/kg tramadol bolus will give. | 24 hour |