This trial is active, not recruiting.

Condition hemorrhoidectomy
Treatments eutectic mixture, placebo, lidocaine 2,5%; prilocaine 2,5%
Phase phase 2/phase 3
Sponsor Federal University of São Paulo
Collaborator Cristália Produtos Químicos Farmacêuticos Ltda.
Start date April 2010
End date February 2011
Trial size 144 participants
Trial identifier NCT00932542, CRT054


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
eutectic mixture
The eutectic mixture of lidocaine + prilocaine + bupivacaine.
(Placebo Comparator)
(Active Comparator)
lidocaine 2,5%; prilocaine 2,5%
lidocaine 2,5%; prilocaine 2,5%

Primary Outcomes

Reduction of pain evaluated by the analgesics demand.
time frame: Follow-up termination (1 month)

Secondary Outcomes

Pain reduction by VAS
time frame: Follow-up termination (1 month)
Tolerability by the adverse events incidence
time frame: Follow-up termination (1 month)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title "Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.