NCT02445599

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Debrecen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Inadequate or Impaired Respiratory Function

Interventions

Type	Name	Description
DRUG	Diclofenac	Orally 100 mg Diclofenac, administered 1 hour before surgery
DRUG	Midazolam	5 mg Dormicum intramuscularly, administered 1 hour before surgery
DRUG	Atropine	0.5 mg Atropine intramuscularly, administered 1 hour before surgery
DRUG	bucain + fentanyl	Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.
DRUG	Nalbuphine	1st choice for rescue analgetic 10-20 mg intravenously
DRUG	Diclofenac	2nd choice for rescue analgetic 250ml intravenously
DRUG	Metamizole-sodium	Additional rescue analgetic 2g intravenously
DRUG	Tramadol	Additional rescue analgetic 100mg intravenously

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-05-15
• Last updated: 2017-03-09

Locations

1 site across 1 country: Hungary