Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain
Condition: Pain; Inadequate or Impaired Respiratory Function
MeSH terms: Shoulder Pain; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to examine if the hyposthesis of the preventive analgestic
      characteristic of diclofenac given preoperatively has any effect on postoperative thoracic
      wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption
      and the postoperative lung function test values.
    

Detailed description: 
      Introduction Thoracotomies are thought to be one of the most difficult surgical incisions to
      deal with post-operatively, because they are extremely painful and the pain can prevent the
      patient from breathing effectively. Currently in our institute the surgical and
      post-operative anelgesia are managed by the combination of local anesthetics and opioid pain
      killers through an epidural cannula. In addition the investigators give diclofenac
      intravenously (from the 2nd day after the operation per os) as well as nalbuphin is given
      intravenously to the patients if it is necesserary.

      By definition pre-emptive analgesia means that the treatment of pain is initiated before the
      surgical procedure by analgetics or nerve blockade techniques. The purpose of this method is
      to inhibit the production of inflammatory mediators and the prevention of the pain stimulus
      entering the central nervous system. As a result of the pre-emptive antinociceptive
      treatment, the quantity of post-operative medications can be decreased, the analgesia has
      less complications and the patients are more satisfied.

      In the study the researchers would like to examine the pre-emptive analgetic effect of
      diclofenac.

      Patients and methods:

      Patients undergoing thoracotomy are divided into two groups.:

        -  Study Group: 100mg diclofenac per os (n=50)

        -  Control Group: patients do not get diclofenac premedication (n=50) The investigators
           examine every patient for five days: they record the patients' pain with the help of the
           Visual Analogue Scale (VAS). We measure the analgetic consumption in intramuscular
           morphin equivalent dose and the local anesthetic consumption via epidural cannula
           seperately. The lung function testing was carried out two times postoperatively with the
           help of the MIR Spirolab II mobil spirometer.
    

Intervention name(s): Diclofenac; Midazolam; Atropine; bucain + fentanyl; Nalbuphine; Diclofenac; Metamizole-sodium; Tramadol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Orally 100 mg Diclofenac, administered 1 hour before surgery; 5 mg Dormicum intramuscularly, administered 1 hour before surgery; 0.5 mg Atropine intramuscularly, administered 1 hour before surgery; Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.; 1st choice for rescue analgetic 10-20 mg intravenously; 2nd choice for rescue analgetic 250ml intravenously; Additional rescue analgetic 2g intravenously; Additional rescue analgetic 100mg intravenously
Other intervention name(s): Diclofenac Stada 100 mg retard; Dormicum 5mg/ml; Atropine 1 mg/ml; Nubain 20mg/2ml; Neodolpasse 75 mg/ 250ml; Algopyrin 2g/2ml; Contramal 100mg/2ml
Intervention MeSH terms: Dipyrone; Diclofenac; Atropine; Midazolam; Fentanyl; Tramadol; Nalbuphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thoracotomy; pain management; analgesia; postoperative care; premedication; preventive