Effect of Ketamine Addition to Lidocaine in Rhinoplasty

Phase 4

Completed

• Conditions: Nose Deformities, Acquired
• Interventions: Drug: Lidocaine 2 %; Drug: Ketamine plus Lidocaine; Drug: Saline

• Registration Number: NCT01827020
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Study First Submitted: 2013-03-28
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-08
• Last Update Submitted: 2013-04-08
• Study First Posted: 2013-04-09
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L (number of participants=30)	Lidocaine 2 %	After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity.
Group K (number of participants=30)	Ketamine plus Lidocaine	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 S (number of participants=30)	Saline	After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

Turgut Ozal Medical Center; 🇹🇷 Malatya, Turkey