Clinical trial NCT02445599: Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Inadequate or Impaired Respiratory Function
Keywords: thoracotomy
pain management
analgesia
postoperative care
premedication
preventive
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 10% reduction of the thoracotomy pain recorded by VAS score.
timeFrame: 5 days
Secondary outcomes:
measure: 10% reduction of the shoulder pain recorded by VAS score.
timeFrame: 5 days
Other outcomes:
measure: Analgetic need during the first five postoperative days.
timeFrame: Participants were followed for 5 days postoperatively
measure: Postoperative complications during the first five postoperative days
timeFrame: Participants were followed for 5 days postoperatively
measure: Intraoperative fentanyl use
timeFrame: Participants were followed during the operation on day 1
measure: Epidurally administered local anethetics
timeFrame: Participants were followed for 5 days postoperatively
measure: Comparing the pre- and postoperative lung function test values
timeFrame: Participants were followed for 5 days postoperatively
Locations:
city: Debrecen
country: Hungary
facility: UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
state: Hajdú-Bihar
Study officials:
affiliation: UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032
name: Béla Fülesdi, MD,PhD,DSci
role: PRINCIPAL_INVESTIGATOR
References:
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