Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

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

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.

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

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