Effect of Ketamine Addition to Lidocaine in Rhinoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

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.

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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.

Conditions

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Nose Deformities, Acquired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group L (number of participants=30)

After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity.

Group Type ACTIVE_COMPARATOR

Lidocaine 2 %

Intervention Type DRUG

12 mL lidocaine 2% 1mg/kg

Group K (number of participants=30)

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.

Group Type ACTIVE_COMPARATOR

Ketamine plus Lidocaine

Intervention Type DRUG

ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL

Group S (number of participants=30)

After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

12 mL saline (0.9% isotonic solution)

Interventions

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Lidocaine 2 %

12 mL lidocaine 2% 1mg/kg

Intervention Type DRUG

Ketamine plus Lidocaine

ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL

Intervention Type DRUG

Saline

12 mL saline (0.9% isotonic solution)

Intervention Type DRUG

Other Intervention Names

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preincisional infiltration of lidocaine preincisional infiltration of ketamine plus lidocaine preincisional infiltration of saline

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No