Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

Study Overview
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Brief Summary
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Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac, referred as treatment B) in benign anorectal surgery.

Detailed Description
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120 patients were randomly assigned to two groups (60 in each group). The study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre. Treatment with CLIFE 1 and CLIFE 2 was applied from day 1 to day 6 post-surgery

Official Title
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Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery

Conditions
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Fissure;Anal, Fistula;Rectal, Hemorrhoids

Intervention / Treatment
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* Drug: anesthesics plus antiinflammatory, CLIFE1
* Drug: local anesthesics, CLIFE2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids Use of subarachnoid anesthesia with lidocaine Exclusion Criteria: Allergy or Hypersensitivity to lidocaine or other local anesthesics. Patients not accepting subarachnoid anesthesia Patients with general anesthesia Hypersensitivity or contraindication to acetylsalicylic acid. History of gastrointestinal hemorrhage or perforation due to nonsteroidal anti-inflammatory drugs (NSAIDs) use Active or relapsing peptic ulcer/gastrointestinal hemorrhage Serious heart failure. Active Crohn disease Active ulcerative colitis Moderate or sever renal failure Severe liver disfunction Coagulation disorders requiring treatment with anticoagulant drugs Proctitis (due to autoimmune disease, foreign substances, sucally transmitted diseases Treatment with: Beta blockers, calcium channel blockers (verapamil and diltiazem), anti-arrhythmics (digoxin, amiodarone), ivabradine, lithium, steroids Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clife1 gel (lidocaine plus diclofenac)<br>Clife1 gel (lidocaine plus diclofenac) Topical gel containing lidocaine (2%) plus diclofenac (0.5%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6 | Drug: anesthesics plus antiinflammatory, CLIFE1<br>* anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory<br>* Other names: CLIFE1 topical gel;|
| Active Comparator: Clife2 gel (lidocaine)<br>Clife2 gel (lidocaine) Topical gel containing lidocaine (2%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6 | Drug: local anesthesics, CLIFE2<br>* local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics<br>* Other names: CLEFE2 topical gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean level of pain, as assessed by visual analog scale (VAS) |  | 3 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean level of pain (VAS) at day 3 post-surgery |  | 6 days post-surgery | 
| Level of pain (VAS), assessed by Andersen scale |  | 6 days post-surgery | 
| Pain relief | Question about pain relief in comparison with the last application (scores from 0 to 4). | 6 days post-surgery | 
| analgesics use |  | 6 days post-surgery | 
| patient satisfaction | Satisfaction questionnaire about the efficacy of treatment (6 levels) | 6 days post-surgery | 
| demographic and clinical characteristics-1 | sex | baseline | 
| demographic and clinical characteristics-2 | age | baseline | 
| safety evaluation as assessed by recording fo adverse events | recording of adverse events | 6 days post-surgery |