Effect of Ketamine Addition to Lidocaine in Rhinoplasty

Ketamine

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.

Intervention / Treatment

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

Condition or Disease

  • Nose Deformities, Acquired

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 50 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2013
    Primary Completion: Feb 01, 2013 ACTUAL
    Completion Date: Mar 01, 2013 ACTUAL
    Study First Posted: Apr 09, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 08, 2013

    Sponsors / Collaborators

    Lead Sponsor: Inonu University
    Responsible Party: N/A

    Location

    Malatya, Turkey

    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.

    Participant Groups

    • After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity.

    • 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.

    • After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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

    • At the end of postoperative 24 h, the patient satisfaction will examine by a score as (1 poor, 2 middle, 3 good, 4 perfect)

    • 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

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

    More Details

    NCT Number: NCT01827020
    Other IDs: Mukadder
    Study URL: https://clinicaltrials.gov/study/NCT01827020
    Last updated: Sep 29, 2023