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Completed

NCT Number: NCT01827020

Effect of Ketamine Addition to Lidocaine 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.

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Key information

Conditions

Nose Deformities, Acquired Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine 2 %

Drug

12 mL lidocaine 2% 1mg/kg

Other names: preincisional infiltration of lidocaine

Ketamine plus Lidocaine

Drug

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

Other names: preincisional infiltration of ketamine plus lidocaine

Saline

Drug

12 mL saline (0.9% isotonic solution)

Other names: preincisional infiltration of saline

Primary outcomes

  1. Postoperative pain scores on the Visual Analogue Scale

    Time frame: 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 outcomes

  1. Patient satisfaction

    Time frame: 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)

  2. Analgesic demand

    Time frame: 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.

Other outcomes

  1. Number of participants with adverse effects as a measure of safety and tolerability

    Time frame: 24 hour

    Sedation, nausea and vomiting, dizziness, and hallucination will examine as an adverse effect in all patients.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 9, 2013
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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