Continuous Lornoxicam Infusion for Orthopaedic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01718756
First received: October 28, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Closed Non Comminuted Long Bone Fractures
Drug: Placebo
Drug: Continuous infusion
Drug: Scheduled
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • postoperative patient controlled morphine consumption [ Time Frame: 24 hours and 48 hours after surgery ] [ Designated as safety issue: No ]
    The cumulative morphine consumption during the first 24 and 48 postoperative hours were recorded.


Secondary Outcome Measures:
  • Quality of analgesia [ Time Frame: every two hours for 24 hours after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Bone non-union [ Time Frame: for 3 months after surgery ] [ Designated as safety issue: Yes ]
  • postoperative sedation [ Time Frame: every two hours for 24 hours after surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Lornoxicam adverse effects [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: Yes ]
    the presence of nausea, vomiting, gastritis, reflux esophagitis, headache, bleeding, bronchospasm, sweating, allergy, thrombocytopenia, bleeding, ecchymosis, or increases in liver transaminases.


Estimated Enrollment: 96
Study Start Date: June 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
The placebo group received 12 hourly boluses of 0.9% saline, followed by a constant infusion for 48 hrs after surgery.
Drug: Placebo
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
Drug: Scheduled
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical class I to III
  • Age from 18 to 55 years
  • Closed non comminuted long bone fractures
  • Elective orthopaedic fracture surgery
  • General anaesthesia

Exclusion Criteria:

  • Hypersensitivity to lornoxicam
  • Gastrointestinal ulceration or bleeding
  • Cardiac diseases
  • Pulmonary diseases
  • Hepatic diseases
  • Renal diseases
  • Clotting diseases
  • Bleeding diseases
  • Bronchial asthma
  • Diabetes mellitus
  • Peripheral arterial occlusive disease
  • Morbid obesity
  • Pregnancy
  • Alcohol or drug abuse
  • Receiving other NSAIDs a day before surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718756

Contacts
Contact: Mohamed R El Tahan, MD +966569371849 mohamedrefaateltahan@yahoo.com

Locations
Egypt
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         
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Mohamed R El Tahan, MD College of Medicine, Mansoura University
  More Information

No publications provided

Responsible Party: Mohamed R El Tahan, Associate Professor of Anesthesiology & SICU, Mansoura University
ClinicalTrials.gov Identifier: NCT01718756     History of Changes
Other Study ID Numbers: R/55
Study First Received: October 28, 2012
Last Updated: October 30, 2012
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Mansoura University:
Orthopaedic
General anaesthesia
lornoxicam
patient controlled analgesia
morphine consumption

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Anesthetics
Lornoxicam
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2014