Hemorrhoidectomy Clinical Trial
— CRT054Official title:
"Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"
Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be operated and discharged at the same day in a day hospital clinic. During the fourteen days recovery period, they will apply the study medication to the anal region 4 times daily. The Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol demand will be tabulated. A rescue medication for analgesia will be provided (sodium diclofenac IM).
Status | Active, not recruiting |
Enrollment | 144 |
Est. completion date | November 2012 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: male and female patients, older than 18, having internal hemorrhoid
disease grade III or IV with indication of elective surgery, anesthetic risk ASA 1 or 2;
able to read and write. Exclusion criteria: allergy or hypersensitivity to the mixture components, perianal fistulas, fissures, ulcers, infectious and inflammatory processes or tumors to the anal region, chronic diarrhea, megacolon or colonic anatomical deformities, hemorrhoidal thrombosis, gangrene or any condition that changes the indication from elective to urgent, previous surgery to anal-rectal region, history or clinical signs of diabetes mellitis type I or II, pregnancy, intense anxiety or important emotional disorder, participation in any clinical trial within the 3 months preceding the inclusion, investigatorĀ“s opinion. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Clínica Reis Neto | Campinas | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Cristália Produtos Químicos Farmacêuticos Ltda. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of pain evaluated by the analgesics demand. | Follow-up termination (1 month) | No | |
Secondary | Pain reduction by VAS | Follow-up termination (1 month) | No | |
Secondary | Tolerability by the adverse events incidence | Follow-up termination (1 month) | Yes |
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