The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery
Rakstu tulkošanu var veikt tikai reģistrēti lietotāji
Ielogoties Reģistrēties
Saite tiek saglabāta starpliktuvē
StatussPabeigts
Sponsori
Ataturk University
KLĪNISKĀ IZPĒTE: NCT03036605
BioSeek: NCT03036605
Atslēgvārdi
Abstrakts
Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis, prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to pain, therefore the most common problems after surgery are postoperative pain and anxiety during removal of the nasal packing. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics, local anesthetics infiltration into nasal packing).
Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain. Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces postoperative nausea and vomiting incidance.
Datumi
| Pēdējoreiz pārbaudīts: | 05/31/2017 |
| Pirmais iesniegtais: | 01/26/2017 |
| Paredzētā reģistrācija iesniegta: | 01/26/2017 |
| Pirmais izlikts: | 01/29/2017 |
| Pēdējais atjauninājums iesniegts: | 06/05/2017 |
| Pēdējā atjaunināšana ievietota: | 06/06/2017 |
| Faktiskais studiju sākuma datums: | 03/14/2017 |
| Paredzamais primārās pabeigšanas datums: | 03/31/2017 |
| Paredzamais pētījuma pabeigšanas datums: | 05/14/2017 |
Stāvoklis vai slimība
Nasal Surgery
Iejaukšanās / ārstēšana
Drug: Bupivacaine
Drug: Group Bupivacaine+Dexamethasone
Fāze
Fāze 4
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Active Comparator: Group Bupivacaine 4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides | |
| Active Comparator: Group Bupivacaine+Dexamethasone 4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides | Drug: Group Bupivacaine+Dexamethasone 8 mg Dexamethasone |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - American Society of Anesthesiologist's physiologic state I-II patients undergoing nasal surgery Exclusion Criteria: - chronic pain - bleeding disorders - renal or hepatic insufficiency - patients on chronic non-steroidal anti-inflammatory medications - emergency cases |
Rezultāts
Primārie rezultāti
1. Analgesic consumption [Postoperative 24 hours]
Analgesic consumption first 24 hours
Sekundārie iznākuma mērījumi
1. Visual analog pain score [postoperative first hour]
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
2. Visual analog pain score [postoperative second hour]
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
3. Visual analog pain score [postoperative 4th hour]
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.
4. Visual analog pain score [postoperative 8th hour]
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.
5. Visual analog pain score [postoperative 12th hour]
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
6. Visual analog pain score [postoperative 24th hour]
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.
