Inadequate or Impaired Respiratory Function, Pain
Conditions
Keywords
thoracotomy, pain management, analgesia, postoperative care, premedication, preventive
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.
Interventions
DRUGTramadol
Additional rescue analgetic 100mg intravenously
DRUGDiclofenac
Orally 100 mg Diclofenac, administered 1 hour before surgery
DRUGMidazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
DRUGAtropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
DRUGbucain + fentanyl
Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.
DRUGNalbuphine
1st choice for rescue analgetic 10-20 mg intravenously
DRUGMetamizole-sodium
Additional rescue analgetic 2g intravenously
Sponsors
University of Debrecen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10% reduction of the thoracotomy pain recorded by VAS score. | 5 days | Our main goal is to achieve 10% reduction of the thoracotomy pain recorded by VAS score, compared to the non-diclofenac control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10% reduction of the shoulder pain recorded by VAS score. | 5 days | Our second goal is to achieve 10%reduction of the shoulder pain recorded by VAS score, compared to the non-diclofenac control group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative fentanyl use | Participants were followed during the operation on day 1 | Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well. |
| Analgetic need during the first five postoperative days. | Participants were followed for 5 days postoperatively | The total amount of administered analgetics were recorded during the first five postoperative days and then converted into intramuscular morphine equivalents. |
| Comparing the pre- and postoperative lung function test values | Participants were followed for 5 days postoperatively | Comparing the pre- and postoperative lung function test values with and after the removal of chest drains. The measurement were executed by the MIR Spirolab II bedside spirometer. |
| Epidurally administered local anethetics | Participants were followed for 5 days postoperatively | The total amount of epidurally administered local anesthetic were recorded during the first five postoperative days. |
| Postoperative complications during the first five postoperative days | Participants were followed for 5 days postoperatively | Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well. Postoperative complications such as bleeding at the surgical site, gastrointestinal problems or kidney dysfunctions were also registered. |
Countries
Hungary
Outcome results
None listed