- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02660749
The Effect Of Multimodal Analgesia On Chronic Pain
Effekten av kombinasjon av tramadol, metamizol og dexketoprofen på kronisk smerteutvikling etter hjertekirurgi
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Both female and male participants are taking part in the study.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
neuropathic pain assesement by DN4 score after minithoracotomy
Tidsramme: outcome measure assessed 3 months after the surgery
|
outcome measure assessed 3 months after the surgery
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: H. Gul Baytan Yildiz, MD, republic of turkey ministry of health
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2015-PMS-41
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