Effect of Ketamine Addition to Lidocaine in Rhinoplasty

Nose Deformities, Acquired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827020
• Other study ID #: Mukadder
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2013
• Last updated: April 8, 2013
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nose Deformities, Acquired

Intervention

Drug:
• Lidocaine 2 %
12 mL lidocaine 2% 1mg/kg
• Ketamine plus Lidocaine
ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL
• Saline
12 mL saline (0.9% isotonic solution)

Locations

Country	Name	City	State
Turkey	Turgut Ozal Medical Center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes