Trial | NCT02961855  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    diclofenac lidocaine ...

  • Study Participants

    120
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
Study Started
Jan 31
2011
Primary Completion
Jan 31
2013
Study Completion
Dec 31
2013
Last Update
Nov 15
2016
Estimate

Drug anesthesics plus antiinflammatory, CLIFE1

anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory

  • Other names: lidocaine plus diclofenac, CLIFE1 topical gel

Drug local anesthesics, CLIFE2

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

  • Other names: lidocaine, CLEFE2 topical gel

Clife1 gel (lidocaine plus diclofenac) Experimental

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

Clife2 gel (lidocaine) Active Comparator

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

Criteria 

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
No Results Posted