Eutectic Mixture for Hemorrhoidectomy Postoperative

Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00932542

Acronym

CRT054

Enrollment

144

Registered

2009-07-03

Start date

2010-04-30

Completion date

2012-11-30

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoidectomy

Keywords

Hemorrhoidectomy

Brief summary

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).

Interventions

DRUGEutectic mixture

The eutectic mixture of lidocaine + prilocaine + bupivacaine.

DRUGplacebo

placebo

DRUGlidocaine 2,5%; prilocaine 2,5%

lidocaine 2,5%; prilocaine 2,5%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026