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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anesthesics plus antiinflammatory, CLIFE1 | Drug | anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean level of pain, as assessed by visual analog scale (VAS) | 3 days post-surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| D012003 | Rectal Fistula |
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000893 | Anti-Inflammatory Agents |
| D008012 | Lidocaine |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000083 | Acetanilides |
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|
| local anesthesics, CLIFE2 | Drug | local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics |
|
|
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 |
| D004066 |
| Digestive System Diseases |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |