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

Overview

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

Full Title of Study: “Phase 4 Study of Intra-articular Dexmedetomidine Adding to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2012

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.

Interventions

  • Drug: Levobupivacaine
    • intraarticular
  • Drug: Dexmedetomidine
    • intraarticular 1 ml (100 mcg)
  • Drug: Morphine
    • intravenously, patient-controlled analgesia

Arms, Groups and Cohorts

  • Active Comparator: Levobupivacaine
    • Intraarticular 19 ml 0.5% levobupivacaine and 1 ml 0.9% sodium chloride administered. postoperative morphine administered for analgesia
  • Active Comparator: Dexmedetomidine
    • Intraarticular 19 ml 0.5% levobupivacaine and 1 ml (100 mcg/ml) dexmedetomidine administered, postoperative morphine used for analgesia

Clinical Trial Outcome Measures

Primary Measures

  • Analgesic consumption
    • Time Frame: up to 48 hours

Secondary Measures

  • blood pressure
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: postoperative 0, 30, 60, 90, 120 minutes in the PACU, 4, 6, 12, 24, 48 hours
  • Visual Analog Scale-movement
    • Time Frame: postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TC Erciyes University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ayse Ulgey, Assisstant Professor – TC Erciyes University
  • Overall Official(s)
    • Resul Altuntas, MD, Principal Investigator, TC Erciyes University
    • Ayse Ulgey, Ast Prof, Study Director, TC Erciyes University

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