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- Essai clinique NCT02660749
The Effect Of Multimodal Analgesia On Chronic Pain
L'effet de l'association tramadol, métamizol et dexkétoprofène sur le développement de la douleur chronique après une chirurgie cardiaque
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Both female and male participants are taking part in the study.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
neuropathic pain assesement by DN4 score after minithoracotomy
Délai: outcome measure assessed 3 months after the surgery
|
outcome measure assessed 3 months after the surgery
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: H. Gul Baytan Yildiz, MD, republic of turkey ministry of health
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2015-PMS-41
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