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

Phase 4 Study of Intra-articular Dexmedetomidine Adding to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Dexmedetomidine; Drug: Morphine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analgesic consumption	up to 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 8, 2013

Study Record Updates

• Last Update Posted (Estimate): August 8, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Analgesia; Dexmedetomidine; Arthroscopic knee surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Morphine; Levobupivacaine
• Other Study ID Numbers: 2011/329 (Registry Identifier: Erciyes University Ethic Committe)