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

University of Debrecen3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain Inadequate or Impaired Respiratory Function

Interventions

DiclofenacDRUG

Orally 100 mg Diclofenac, administered 1 hour before surgery

MidazolamDRUG

5 mg Dormicum intramuscularly, administered 1 hour before surgery

AtropineDRUG

0.5 mg Atropine intramuscularly, administered 1 hour before surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, Hungary

Outcomes

Primary Outcomes

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.

Time frame: 5 days

Secondary Outcomes

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.

Time frame: 5 days

Data from ClinicalTrials.gov

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