Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain, as Well as the Changes of the Postoperative Breathing Function Values, a Randomized, Controlled, Prospective Trial

Conditions
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Pain, Inadequate or Impaired Respiratory Function

Intervention / Treatment
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* Drug: Diclofenac
* Drug: Midazolam
* Drug: Atropine
* Drug: bucain + fentanyl
* Drug: Nalbuphine
* Drug: Diclofenac
* Drug: Metamizole-sodium
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 100 thoracotomy patients who agreed to take part in our study and signed a consent age 18-80 years ASA I-III men/women equally thoracotomies are managed with using intratracheal double lumen tube insertion of thoracic epidural cannula and during the operation administration of 1mg/ml bucain, 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed Exclusion Criteria: acute operation diclofenac allergy in the anamnesis the lack of thoracic epidural cannula

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac group<br>Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions. Every patient recieved additional thoracic epidural analgesia during and after the surgery. As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively. | Drug: Diclofenac<br>* Orally 100 mg Diclofenac, administered 1 hour before surgery<br>* Other names: Diclofenac Stada 100 mg retard;Drug: Midazolam<br>* 5 mg Dormicum intramuscularly, administered 1 hour before surgery<br>* Other names: Dormicum 5mg/ml;Drug: Atropine<br>* 0.5 mg Atropine intramuscularly, administered 1 hour before surgery<br>* Other names: Atropine 1 mg/ml;Drug: bucain + fentanyl<br>* Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.<br>Drug: Nalbuphine<br>* 1st choice for rescue analgetic 10-20 mg intravenously<br>* Other names: Nubain 20mg/2ml;Drug: Diclofenac<br>* 2nd choice for rescue analgetic 250ml intravenously<br>* Other names: Neodolpasse 75 mg/ 250ml;Drug: Metamizole-sodium<br>* Additional rescue analgetic 2g intravenously<br>* Other names: Algopyrin 2g/2ml;Drug: Tramadol<br>* Additional rescue analgetic 100mg intravenously<br>* Other names: Contramal 100mg/2ml;|
| Experimental: Control group<br>Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions. Every patient recieved additional thoracic epidural analgesia during and after the surgery. As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively. | Drug: Midazolam<br>* 5 mg Dormicum intramuscularly, administered 1 hour before surgery<br>* Other names: Dormicum 5mg/ml;Drug: Atropine<br>* 0.5 mg Atropine intramuscularly, administered 1 hour before surgery<br>* Other names: Atropine 1 mg/ml;Drug: bucain + fentanyl<br>* Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.<br>Drug: Nalbuphine<br>* 1st choice for rescue analgetic 10-20 mg intravenously<br>* Other names: Nubain 20mg/2ml;Drug: Diclofenac<br>* 2nd choice for rescue analgetic 250ml intravenously<br>* Other names: Neodolpasse 75 mg/ 250ml;Drug: Metamizole-sodium<br>* Additional rescue analgetic 2g intravenously<br>* Other names: Algopyrin 2g/2ml;Drug: Tramadol<br>* Additional rescue analgetic 100mg intravenously<br>* Other names: Contramal 100mg/2ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10% reduction of the thoracotomy pain recorded by VAS score. | Our main goal is to achieve 10% reduction of the thoracotomy pain recorded by VAS score, compared to the non-diclofenac control group. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10% reduction of the shoulder pain recorded by VAS score. | Our second goal is to achieve 10%reduction of the shoulder pain recorded by VAS score, compared to the non-diclofenac control group. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracotomy, pain management, analgesia, postoperative care, premedication, preventive