Effect of Ketamine Addition to Lidocaine in Rhinoplasty

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

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

Study Overview

• Status: Completed
• Conditions: Nose Deformities, Acquired
• Intervention / Treatment: Drug: Lidocaine 2 %; Drug: Ketamine plus Lidocaine; Drug: Saline

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44315
    • Turgut Ozal Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Lidocaine 2 %; 12 mL lidocaine 2% 1mg/kg; Other Names: preincisional infiltration of lidocaine
Active Comparator: 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.	Drug: Ketamine plus Lidocaine; ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL; Other Names: preincisional infiltration of ketamine plus lidocaine
Placebo Comparator: 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.	Drug: Saline; 12 mL saline (0.9% isotonic solution); Other Names: preincisional infiltration of saline

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse effects as a measure of safety and tolerability	Sedation, nausea and vomiting, dizziness, and hallucination will examine as an adverse effect in all patients.	24 hour

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Mukadder Sanli, MD, Turgut Ozal Medical Center

Publications and helpful links

General Publications

• Honarmand A, Safavi M, Karaky H. Preincisional administration of intravenous or subcutaneous infiltration of low-dose ketamine suppresses postoperative pain after appendectomy. J Pain Res. 2012;5:1-6. doi: 10.2147/JPR.S26476. Epub 2011 Dec 30.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 8, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Nose Deformities, Acquired; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Lidocaine
• Other Study ID Numbers: Mukadder