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Effect of Ketamine Addition to Lidocaine in Rhinoplasty

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ClinicalTrials.gov Identifier: NCT01827020
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Mukadder Sanli, 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.

Condition or disease Intervention/treatment Phase
Nose Deformities, Acquired Drug: Lidocaine 2 % Drug: Ketamine plus Lidocaine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty
Study Start Date : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

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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 Name: 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 Name: 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 Name: preincisional infiltration of saline




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827020


Locations
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Turkey
Turgut Ozal Medical Center
Malatya, Turkey, 44315
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Mukadder Sanli, MD Turgut Ozal Medical Center

Publications of Results:
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Responsible Party: Mukadder Sanli, MD, Inonu University
ClinicalTrials.gov Identifier: NCT01827020     History of Changes
Other Study ID Numbers: Mukadder
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Nose Deformities, Acquired
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents