NCT01918917

Brief Summary

The purpose of this study to search efficacy of intra-articular dexmedetomidine addition to levobupivacaine for postoperative analgesia in arthroscopic knee surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
Last Updated

August 8, 2013

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

August 6, 2013

Last Update Submit

August 7, 2013

Conditions

Pain

Keywords

Arthroscopic knee surgeryDexmedetomidineAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Analgesic consumption

    up to 48 hours

Secondary Outcomes (4)

  • blood pressure

    before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours

  • heart rate

    before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours

  • Visual Analog Scale-rest

    postoperative 0, 30, 60, 90, 120 minutes in the PACU, 4, 6, 12, 24, 48 hours

  • Visual Analog Scale-movement

    postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours

Study Arms (2)

Levobupivacaine

ACTIVE COMPARATOR

Intraarticular 19 ml 0.5% levobupivacaine and 1 ml 0.9% sodium chloride administered. postoperative morphine administered for analgesia

Drug: LevobupivacaineDrug: DexmedetomidineDrug: Morphine

Dexmedetomidine

ACTIVE COMPARATOR

Intraarticular 19 ml 0.5% levobupivacaine and 1 ml (100 mcg/ml) dexmedetomidine administered, postoperative morphine used for analgesia

Drug: DexmedetomidineDrug: Morphine

Interventions

LevobupivacaineDRUG

intraarticular

Also known as: chirocaine 0.5%
Levobupivacaine
DexmedetomidineDRUG

intraarticular 1 ml (100 mcg)

Also known as: precedex, 100mcg/ml
DexmedetomidineLevobupivacaine
MorphineDRUG

intravenously, patient-controlled analgesia

Also known as: morphine HCL, 10 mg
DexmedetomidineLevobupivacaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 yo
  • scheduled for arthroscopic knee surgery

You may not qualify if:

  • younger than 18 yo
  • known allergy relevant drugs
  • contraindication for general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAgnosia

Interventions

LevobupivacaineDexmedetomidineMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Resul Altuntas, MD

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

  • Ayse Ulgey, Ast Prof

    TC Erciyes University

    STUDY DIRECTOR

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
Assisstant Professor

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 8, 2013

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 8, 2013

Record last verified: 2013-08