Continuous Lornoxicam Infusion for Orthopaedic Surgery

NCT01718756 | Suspended Phase 1 DMC

• 1 other identifier: R/55
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Closed Non Comminuted Long Bone Fractures

Keywords

Orthopaedic; General anaesthesia; lornoxicam; patient controlled analgesia; morphine consumption

Outcome Measures

Primary Outcomes (1)

• postoperative patient controlled morphine consumption

  The cumulative morphine consumption during the first 24 and 48 postoperative hours were recorded.

  24 hours and 48 hours after surgery

Secondary Outcomes (6)

• Quality of analgesia

  every two hours for 24 hours after surgery

• platelet functions

  daily after surgery for three days

• Bone non-union

  for 3 months after surgery

• postoperative sedation

  every two hours for 24 hours after surgery

• Nausea and vomiting

  every two hours for 24 hours after surgery

Other Outcomes (1)

• Lornoxicam adverse effects

  48 hours after surgery

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The placebo group received 12 hourly boluses of 0.9% saline, followed by a constant infusion for 48 hrs after surgery.

Drug: Placebo

Scheduled

ACTIVE COMPARATOR

They received a 12 hourly boluses of lornoxicam followed by a constant infusion of 0.9% saline, for 48 hrs after surgery

Drug: Scheduled

Continuous infusion

ACTIVE COMPARATOR

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

Interventions

Placebo DRUG

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.

Placebo

Continuous infusion DRUG

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

Continuous infusion

Scheduled DRUG

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.

Scheduled

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Anesthesiology Dept., College of Medicine, Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Appointments and Schedules

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Mohamed R El Tahan, MD

  College of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & SICU

Study Record Dates

• First Submitted: October 28, 2012
• First Posted: October 31, 2012
• Study Start: June 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

EG (1)