Continuous Lornoxicam Infusion for Orthopaedic Surgery
Recruitment status was: Recruiting
Perioperative continuous infusion of lornoxicam would be an effective and safe regimen to reduce the patient controlled morphine consumption after orthopaedic surgery.
After ethical approval, 96 patients scheduled for elective orthopaedic fracture surgery under general anaesthesia were randomly allocated to receive placebo, 12-hourly iv lornoxicam 16 mg or lornoxicam 16 mg followed with continuous infusion of 1.3 mg/hr., for 48 hours after surgery (n=32 per group). Anaesthesia was induced with propofol, sufentanil and rocuronium, and was maintained with 0.5-1 minimum alveolar concentration sevoflurane, sufentanil and rocuronium. Postoperative patient controlled morphine analgesia was used. Changes in heart rate, mean blood pressure and sevoflurane minimum alveolar concentration, visual analogue pain scores, and cumulative patient controlled morphine consumptions and blood loss for 48 hours, platelet functions, bone non-union and the presence of adverse effects were recorded.
|Closed Non Comminuted Long Bone Fractures||Drug: Placebo Drug: Continuous infusion Drug: Scheduled||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Continuous Intravenous Infusion vs. Scheduled Dosing of Lornoxicam on Patient Controlled Morphine Consumption After Orthopaedic Surgery: A Comparative Placebo Study|
- postoperative patient controlled morphine consumption [ Time Frame: 24 hours and 48 hours after surgery ]The cumulative morphine consumption during the first 24 and 48 postoperative hours were recorded.
- Quality of analgesia [ Time Frame: every two hours for 24 hours after surgery ]the use of visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)
- platelet functions [ Time Frame: daily after surgery for three days ]
- Bone non-union [ Time Frame: for 3 months after surgery ]
- postoperative sedation [ Time Frame: every two hours for 24 hours after surgery ]four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep),
- Nausea and vomiting [ Time Frame: every two hours for 24 hours after surgery ]nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting),
- Perioperative blood loss [ Time Frame: Cumulative intraoperative and 24 hours after surgery ]
- Lornoxicam adverse effects [ Time Frame: 48 hours after surgery ]the presence of nausea, vomiting, gastritis, reflux esophagitis, headache, bleeding, bronchospasm, sweating, allergy, thrombocytopenia, bleeding, ecchymosis, or increases in liver transaminases.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
The placebo group received 12 hourly boluses of 0.9% saline, followed by a constant infusion for 48 hrs after surgery.
The placebo group received 12 hourly 20-mL i.v. boluses of 0.9% saline starting 20 min before induction of anaesthesia, followed by a constant infusion at 10 mL/h, for 48 hrs after surgery.
Active Comparator: Scheduled
They received a 12 hourly boluses of lornoxicam followed by a constant infusion of 0.9% saline, for 48 hrs after surgery
The "scheduled" group received an 12 hourly 20-mL i.v. boluses of lornoxicam 0.8 mg/mL starting 20 min before induction of anaesthesia followed by a constant infusion at 10 mL/h of 0.9% saline, for 48 hrs after surgery (supplied by Xefo, JPI, Saudi Arabia), starting 20 min before induction of anaesthesia.
Active Comparator: Continuous infusion
They received boluses of lornoxicam 0.8 mg/mL before induction of anaesthesia followed by a 12 hourly boluses of 0.9% saline and a constant infusion at 10 mL/h of lornoxicam 0.13 mg/mL, for 48 hrs. after surgery.
Drug: Continuous infusion
The "continuous infusion" group received 20-mL i.v. boluses of lornoxicam 0.8 mg/mL starting 20 min before induction of anaesthesia followed by a 12 hourly 20-mL i.v. boluses of 0.9% saline and a constant infusion at 10 mL/h of lornoxicam 0.13 mg/mL, for 48 hrs. after surgery
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718756
|Contact: Mohamed R El Tahan, MDfirstname.lastname@example.org|
|Anesthesiology Dept., College of Medicine, Mansoura University||Recruiting|
|Mansoura, DK, Egypt, 050|
|Sub-Investigator: Salwa Hawas, MD|
|Principal Investigator: Eiad A Ramzy, MD|
|Sub-Investigator: Douaa G Diab, MD|
|Sub-Investigator: Nahla S El Bahnsawy, MD|
|Sub-Investigator: Hany A Mowafi, MD|
|Sub-Investigator: Talal A Albrahimi, MD|
|Principal Investigator:||Mohamed R El Tahan, MD||College of Medicine, Mansoura University|