Effect of Ketamine Addition to Lidocaine in Rhinoplasty

Inonu University

Status and phase: Completed; Phase 4

Conditions: Nose Deformities, Acquired

Treatments: Drug: Lidocaine 2 %; Drug: Saline; Drug: Ketamine plus Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01827020

Mukadder

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Group L (number of participants=30)

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine 2 %

Group K (number of participants=30)

Active Comparator group

Description:

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.

Treatment:

Drug: Ketamine plus Lidocaine

Group S (number of participants=30)

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline