Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids (H1-5)

University Hospital Dubrava

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hemorrhoids

Treatments: Drug: placebo; Drug: 2% lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01961739

PROTOCOL H1-5

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in the therapy of symptomatic hemorrhoids. Efficacy will be determined by:

1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general well-being and improvement since the beginning of treatment as separate components of CORRECTS scale
2. the change in overall CORRECTS values from baseline
3. the change in degree of hemorrhoids from baseline

Full description

This is a double blinded randomized clinical study into the effect of topical 2% lidocaine in patients with symptomatic hemorrhoids.

Calculated sample size is 69 patients per arm, based on expected improvement of pain and healing by 30% at p<0.05 and power goal of 95%. Taking into account a drop-out rate of 50%, total number of 69 patients in each arm is estimated as sufficient to close the study.

Patients will be randomly assigned into 2 arms, arm 1 (treatment): topical 2% lidocaine and arm 2 (control): vaseline base. Each arm will consist of 69 patients. Patients will be assigned to either treatment or control arm according to the randomization table.

• Treatment arm - topical 2% lidocaine. Topical application of 2% lidocaine in vaseline base repeated two times per day,
• Control arm - vaseline base. Topical application of pure vaseline base twice per day.

In addition to the aforementioned topical treatments, all patients will be given written instructions to perform dietary modifications and anal hygiene. All patients with bleeding hemorrhoids will be given Detralex 2 tablets twice per day.

Those patients in whom a technically successful procedure has been completed will be considered as valuable for the efficacy evaluation. A technically successful procedure is defined as the completion of treatment procedures stipulated in this protocol and consists of correct drug dose and frequency of application, adherence to written instructions for dietary modification and anal hygiene and presence at follow-up visits.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically present enlarged hemorrhoids, grade 1-4 (for definition see Appendix 1)
• symptoms of pain or itching
• age 18 years or more
• willing and able to comply with the study
• geographically suitable, meaning with reliable transportation for outpatients to the testing site

Exclusion criteria

• actual pregnancy
• inability to provide informed consent
• any anal topical medication applied in the last 7 days
• any anal surgery (including surgical or instrumental procedures defined in the section 4.3) in the last 60 days
• known allergy to vaseline, lidocaine or Dulcolax
• other anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections
• contraindication for topical anal application of vaseline or lidocaine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups, including a placebo group

2% lidocaine

Experimental group

Description:

topical application, two times per day for 15 consecutive days

Treatment:

Drug: 2% lidocaine

placebo

Placebo Comparator group

Description:

vaseline base applied topically, two times per day for 15 consecutive days

Treatment:

Drug: placebo