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| Sponsor: | Federal University of São Paulo |
|---|---|
| Collaborator: |
Cristália Produtos Químicos Farmacêuticos Ltda. |
| Information provided by: | Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT00932542 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hemorrhoidectomy |
Drug: Eutectic mixture Drug: placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | "Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-Controlled)" |
| Estimated Enrollment: | 64 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Eutectic mixture: Experimental |
Drug: Eutectic mixture
The eutectic mixture of lidocaine 2,125% + prilocaine 2,125% + bupivacaine 0,75%.
|
| placebo: Placebo Comparator |
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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, investigator´s opinion.
Contacts and Locations More Information
| Responsible Party: | Clinica Reis Neto ( Joaquim Simoes Neto ) |
| Study ID Numbers: | CRT054 |
| Study First Received: | June 18, 2009 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00932542 History of Changes |
| Health Authority: | Brazil: National Health Surveillance Agency |
|
Hemorrhoidectomy |
|
Digestive System Diseases Gastrointestinal Diseases Vascular Diseases Hemorrhoids |
Cardiovascular Diseases Intestinal Diseases Rectal Diseases |
