NCT01827020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

1 month

First QC Date

March 28, 2013

Last Update Submit

April 8, 2013

Conditions

Nose Deformities, Acquired

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient satisfaction

    24 hour

  • Analgesic demand

    24 hour

Other Outcomes (1)

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

    24 hour

Study Arms (3)

Group L (number of participants=30)

ACTIVE COMPARATOR

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 %

Group K (number of participants=30)

ACTIVE COMPARATOR

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

Group S (number of participants=30)

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Lidocaine 2 %DRUG

12 mL lidocaine 2% 1mg/kg

Also known as: preincisional infiltration of lidocaine
Group L (number of participants=30)
Ketamine plus LidocaineDRUG

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

Also known as: preincisional infiltration of ketamine plus lidocaine
Group K (number of participants=30)
SalineDRUG

12 mL saline (0.9% isotonic solution)

Also known as: preincisional infiltration of saline
Group S (number of participants=30)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients scheduled for elective rhinoplasty operation under general anesthesia
  • Patients with ASA (American Society of Anesthesiology) class I
  • Patients between 18-50 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

Location

Related 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.

    PMID: 22328829RESULT

MeSH Terms

Conditions

Nose Deformities, Acquired

Interventions

KetamineLidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mukadder Sanli, MD

    Turgut Ozal Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 9, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

TU(1)