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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02961855

Enrollment

120

Registered

2016-11-11

Start date

2011-01-31

Completion date

2013-12-31

Last updated

2016-11-15

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

Conditions

Fissure;Anal, Fistula;Rectal, Hemorrhoids

Brief summary

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

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

Interventions

DRUGanesthesics plus antiinflammatory, CLIFE1

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

DRUGlocal anesthesics, CLIFE2

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
safety evaluation as assessed by recording fo adverse events	6 days post-surgery	recording of adverse events
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	—
demographic and clinical characteristics-2	baseline	age
analgesics use	6 days post-surgery	—
patient satisfaction	6 days post-surgery	Satisfaction questionnaire about the efficacy of treatment (6 levels)
demographic and clinical characteristics-1	baseline	sex
Pain relief	6 days post-surgery	Question about pain relief in comparison with the last application (scores from 0 to 4).

Outcome results

None listed

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