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

TC Erciyes University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Levobupivacaine; Drug: Dexmedetomidine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01918917

2011/329 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Levobupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Morphine

Drug: Dexmedetomidine

Drug: Levobupivacaine

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Morphine

Drug: Dexmedetomidine