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Continuous Lornoxicam Infusion for Orthopaedic Surgery

NCT01718756 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-09-04

No results posted yet for this study

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

Interventions

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.

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

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamed R El Tahan, MD · College of Medicine, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2021-12-31
Completion
2022-02-28

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01718756 on ClinicalTrials.gov