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

T

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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