- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02660749
The Effect Of Multimodal Analgesia On Chronic Pain
Effekten av kombinationen Tramadol, Metamizol och Dexketoprofen på kronisk smärtutveckling efter hjärtkirurgi
This study aimed to show the characteristics and predictors of chronic pain after a mini-thoracotomy. Non-Coronary Heart Surgery patients were scheduled for the study. In patients with acute postoperative period use of tramadol retard, metamizole, and dexketoprofen the effects on the development of chronic pain and its character have been analyzed.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This prospective study analyzed surgical thoracotomy patients treated with analgesic drugs with pain levels equal to or higher than four on the Douleur Neuropathique scale. The screening test for neuropathic pain is the Douleur Neuropathique 4 (DN4). Postoperative 3rd-month DN4 questionnaires are used to predict persistent postoperative neuropathic pain. Patients were separated into two groups with those who developed chronic pain and those who did not on the 3rd-month of post-operation. Demographical characteristics and clinical findings regarding the situation of post-operation 3rd-month pain include but are not limited to; gender, body mass index (BMI), preoperative and postoperative clinical examination status (EUROSCORE), changes in the average VAS scores during hospitalization, neuropathic pain scores, duration of chest drains, duration of cardiopulmonary bypass, cross-clamp time, time under anesthesia, duration of stay in the ICU (hours), duration of pain after being discharged (days), additional drug requests by the patient, and any possible complications that arise. In addition, the presence and distribution of somatic (throbbing, tingling, spasm, tautening, stabbing, scouring), neuropathic (electric shock, burning, numbness, prickling, loss of sense), as well as other symptoms such as allodynia and hyperalgesia experienced by chronic patients three months post-operation were also analyzed and compared non-chronic patients.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Both female and male participants are taking part in the study.
Beskrivning
Inclusion Criteria:
- Patients included between 20-70 years
- ASA 1-4
- Euroscore value lower than 7
- Undergoned non coronary heart surgery (minithoracotomy)
- Intensive care has been discharged from the service in 24 hours , with patients given tramadol retard , metamizol, Dexketoprofen on postoperatif first day to discharged from the hospital.
Exclusion Criteria:
- Diabetes mellitus
- Chronic renal failure
- COPD
- Uncontrolled hypertension
- Epilepsy
- Psychiatric disease
- Malignancy
- Patients with a history of cerebrovascular disease
- Patients with ischemia
- Patients suffering from chronic pain and analgesic use
- Patients taking antidepressants and antiepileptic drug
- Off-pump technique used or redo undergo cases
- Ongoing postoperative time thoracic or mediastinal drains more than 48 hours remaining patients, bleeding or patients who received repeated revisions due to infection
- More than 24 hours remaining in intensive care patients
- Patients with long discharge duration 1 week
- Patients who discontinued due to side effects of tramadol may begin after medicines.
- Postoperative wound infection.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
neuropathic pain assesement by DN4 score after minithoracotomy
Tidsram: outcome measure assessed 3 months after the surgery
|
outcome measure assessed 3 months after the surgery
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: H. Gul Baytan Yildiz, MD, republic of turkey ministry of health
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2015-PMS-41
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .