Authors
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Universidade Federal de Santa Catarina -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2020
INTERVENTION: Drug Duloxetine Hydrochloride Experimental Group: 27 patients undergoing hemorrhoidectomies, which precede the inclusion and exclusion criteria. Receive 1 tablet of Duloxetine 60mg orally, 2 hours before and 24 hours after hemorrhoidectomy. Placebo Group: 27 patients undergoing hemorrhoidectomies, which precede the inclusion and exclusion criteria. Receive 1 placebo tablet (500mg maize starch) orally, 2 hours before and 24 hours after hemorrhoidectomy. The surgical and anesthetic technique is systematically the same in two groups. Patients in both groups were selected at random. The tablets are identical. The medication is administered by a person not directly involved in the study. Hemorrhoidectomy Placebo Effect Procedure/surgery CONDITION: Acute Pain Haemorrhoids Hemorrhoid Disease, Acute Pain. ; Hemorrhoids ; Haemorrhoids ; Acute Pain Hemorrhoids K00‐K93 PRIMARY OUTCOME: Expected outcome 1; Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 6 hours postoperatively. Expected outcome 2; Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 12 hours postoperatively. Expected outcome 3; Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 24 hours postoperatively. Expected outcome 4; Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 48 hours postoperatively. Expected outcome 5; Pain reduction, verified by the visual analog scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement during the first evacuation. Expected outcome 6; Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 8th postoperative day. SECONDARY OUTCOME: Expected outcome 1 ; Decrease in the consumption of morphine, verified by the use of the intravenous pump (morphine 1mg / ml) with patient controlled analgesia, at 6 hours, 12 hours and 24 hours after surgery. Expected outcome 2 ; Incidence of side effects possibly related to the use of duloxetine (dry mouth, nausea, vomiting, dizziness, visual disturbance, headache, etc.), verified through anamnesis and physical examination at 6 hours, 12 hours and 24 hours after surgery. INCLUSION CRITERIA: ASA I and II patients; of both genders; age between 18 and 65 years; elective hemorrhoidectomy due to symptomatic hemorrhoidal disease. Patients who allow the use of their data for research activities after signing their Free and Informed Consent Terms (ICF) by them or a responsible family member.
Epistemonikos ID: b0c7b45a03843d8d04eebe14f2bb5bb252523964
First added on: Aug 24, 2024