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Adding Intra-articular Dexmedetomidine to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT01918917
Collaborator
(none)
60
Enrollment
2
Arms
17.1
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Patients between 18-65 years and with American Society of Anesthesiologists' (ASA) Physical Status class I-II, who were scheduled for arthroscopic knee surgery, were enrolled in a randomised comparative clinical trial. Blinding or masking began in the preoperative holding unit. Exclusion criteria were psychiatric illness, younger than 18 yo, who has analgesic treatment before the surgery and known hypersensitivity to relevant drugs. All patients received a standard anaesthetic protocol; ECG, heart rate, non-invasive blood pressure, oxygen saturation and temperature were monitored. After preoxygenation, general anaesthesia was induced with sodium pentothal 4 to 7 mg/kg, 1 mcg/kg fentanyl and neuromuscular block was achieved with rocuronium 0.5 mg/kg and trachea was intubated. Anesthesia was maintained with desflurane 6% and 50% oxygen in the medical air.

Randomised patients were achieved dexmedetomidine and levobupivacaine or levobupivacaine intra-articularly 10 minutes before medical tourniquet deaerated.

Postoperative analgesia was maintained with morphine in patient-controlled analgesia. Patients postoperative VAS values and analgesic consumptions were recorded in postoperative 24 hours.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 4 Study of Intra-articular Dexmedetomidine Adding to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Levobupivacaine

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

Drug: Levobupivacaine
intraarticular
Other Names:
  • chirocaine 0.5%

    • Drug: Dexmedetomidine
    intraarticular 1 ml (100 mcg)
    Other Names:
  • precedex, 100mcg/ml

    • Drug: Morphine
    intravenously, patient-controlled analgesia
    Other Names:
  • morphine HCL, 10 mg

    		•
    Active Comparator: Dexmedetomidine

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

    Drug: Dexmedetomidine
    intraarticular 1 ml (100 mcg)
    Other Names:
  • precedex, 100mcg/ml

    • Drug: Morphine
    intravenously, patient-controlled analgesia
    Other Names:
  • morphine HCL, 10 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Analgesic consumption [up to 48 hours]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. Visual Analog Scale-rest [postoperative 0, 30, 60, 90, 120 minutes in the PACU, 4, 6, 12, 24, 48 hours]

    4. Visual Analog Scale-movement [postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • older than 18 yo

    • scheduled for arthroscopic knee surgery

    Exclusion Criteria:

    • younger than 18 yo

    • known allergy relevant drugs

    • contraindication for general anesthesia

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • TC Erciyes University

    Investigators

    • Principal Investigator: Resul Altuntas, MD, TC Erciyes University
    • Study Director: Ayse Ulgey, Ast Prof, TC Erciyes University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayse Ulgey, Assisstant Professor, TC Erciyes University
    ClinicalTrials.gov Identifier:
    NCT01918917
    Other Study ID Numbers:
    • 2011/329
    • 2011/329
    First Posted:
    Aug 8, 2013
    Last Update Posted:
    Aug 8, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Ayse Ulgey, Assisstant Professor, TC Erciyes University
    Arthroscopic knee surgery
    Dexmedetomidine
    Analgesia
    Additional relevant MeSH terms:
    Dexmedetomidine
    Morphine
    Levobupivacaine

    Study Results

    No Results Posted as of Aug 8, 2013