Nose Deformities, Acquired
Conditions
Brief summary
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
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.
Interventions
DRUGLidocaine 2 %
12 mL lidocaine 2% 1mg/kg
DRUGKetamine plus Lidocaine
ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL
DRUGSaline
12 mL saline (0.9% isotonic solution)
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores on the Visual Analogue Scale | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 24 hour | At the end of postoperative 24 h, the patient satisfaction will examine by a score as (1 poor, 2 middle, 3 good, 4 perfect) |
| Analgesic demand | 24 hour | At the first day of postoperative period, analgesic requirement will record. When Visual analogue scale \> 40, intravenous 1 mg/kg tramadol bolus will give. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse effects as a measure of safety and tolerability | 24 hour | Sedation, nausea and vomiting, dizziness, and hallucination will examine as an adverse effect in all patients. |
Countries
Turkey (Türkiye)
Outcome results
None listed