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

NCT ID: NCT01918917

Last Updated: 2013-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain

Keywords

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Arthroscopic knee surgery Dexmedetomidine Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levobupivacaine

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

intraarticular

Dexmedetomidine

Intervention Type DRUG

intraarticular 1 ml (100 mcg)

Morphine

Intervention Type DRUG

intravenously, patient-controlled analgesia

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

intraarticular 1 ml (100 mcg)

Morphine

Intervention Type DRUG

intravenously, patient-controlled analgesia

Interventions

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Levobupivacaine

intraarticular

Intervention Type DRUG

Dexmedetomidine

intraarticular 1 ml (100 mcg)

Intervention Type DRUG

Morphine

intravenously, patient-controlled analgesia

Intervention Type DRUG

Other Intervention Names

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chirocaine 0.5% precedex, 100mcg/ml morphine HCL, 10 mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Ulgey

Assisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Resul Altuntas, MD

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Ayse Ulgey, Ast Prof

Role: STUDY_DIRECTOR

TC Erciyes University

Other Identifiers

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2011/329

Identifier Type: REGISTRY

Identifier Source: secondary_id

2011/329

Identifier Type: -

Identifier Source: org_study_id