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

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ClinicalTrials.gov Identifier: NCT01918917
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Ayse Ulgey, TC Erciyes University

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
Pain Drug: Levobupivacaine Drug: Dexmedetomidine Drug: Morphine 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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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 Name: chirocaine 0.5%

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

Drug: Morphine
intravenously, patient-controlled analgesia
Other Name: 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 Name: precedex, 100mcg/ml

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




Primary Outcome Measures :
  1. Analgesic consumption [ Time Frame: up to 48 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Visual Analog Scale-rest [ Time Frame: postoperative 0, 30, 60, 90, 120 minutes in the PACU, 4, 6, 12, 24, 48 hours ]
  4. Visual Analog Scale-movement [ Time Frame: postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918917


Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Resul Altuntas, MD TC Erciyes University
Study Director: Ayse Ulgey, Ast Prof TC Erciyes University
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Responsible Party: Ayse Ulgey, Assisstant Professor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01918917    
Other Study ID Numbers: 2011/329
2011/329 ( Registry Identifier: Erciyes University Ethic Committe )
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: August 8, 2013
Last Verified: August 2013
Keywords provided by Ayse Ulgey, TC Erciyes University:
Arthroscopic knee surgery
Dexmedetomidine
Analgesia
Additional relevant MeSH terms:
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Morphine
Dexmedetomidine
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics