Trial reportClinical and translational gastroenterology2018
Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial.
Trial report in Clinical and translational gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07688031 (Efficacy and Safety of Topical Lidocaine 23%/Tetracaine 7% Ointment Versus Placebo for Post-Hemorrhoidectomy Pain), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy and Safety of Topical Lidocaine 23%/Tetracaine 7% Ointment Versus Placebo for Post-Hemorrhoidectomy Pain: A Double-Blind Randomized Controlled Trial
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Pooled it
- The efficacy of topical sucralfate in improving pain and wound healing after haemorrhoidectomy procedure: A systematic review, meta-analysis, and meta-regression of randomised clinical trials.International wound journal · 2023Pooled it
- Effect of Neibu Huangqi Youhua formula on postoperative wound healing, inflammatory factors and pain mediators of anal fistula.Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2025Trial
- Evaluation of the Effectiveness of a Combination of Chinese Herbal Fumigation Sitz-Bath and Red Ointment in Managing Postoperative Wound Healing and Pain Control in Anal Fistula Patients.Contrast media & molecular imaging · 2022Trial
- PROSPECT guideline for haemorrhoid surgery: A systematic review and procedure-specific postoperative pain management recommendations.European journal of anaesthesiology and intensive care · 2023Article
- Pain Trajectory after Short-Stay Anorectal Surgery: A Prospective Observational Study.Journal of personalized medicine · 2023Article
- Topical Lidocaine plus Diclofenac as a Local Anesthetic Agent in Central Venous Catheterization; a Randomized Controlled Clinical Trial.Archives of academic emergency medicine · 2021Article
- Acupuncture therapy for postoperative pain of anorectal diseases: A systematic review protocol.Medicine · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of this study is to evaluate the efficacy and safety of a topical formulation containing lidocaine plus diclofenac (CLIFE1) compared to lidocaine (CLIFE2), to decrease pain in benign anorectal surgery (BARS) to date not evaluated. More than 50% of patients undergoing BARS, especially hemorrhoidectomy, suffer from moderate and severe postoperative pain. This remains an unresolved problem that could be addressed with the new CLIFE1 topical treatment.
methodsA multicenter, randomized double-blind, active-controlled parallel-group superiority trial, was conducted in two Spanish hospitals. Patients undergoing BARS (hemorrhoids, anal fistula and anal fissure) were randomized at the end of surgery at a 1:1 ratio to receive first dose either CLIFE1 (n = 60) or CLIFE2 (n = 60) anorectal topical treatment, and after every 12 h for the first three postoperative days and once a day from the fourth to sixth. The primary outcome was average of pain decrease after topical treatment, measured with visual analogue scale (VAS) by the patients themselves, the evening in the surgery day and four times daily for the first three postoperative days.
resultsThe results of 120 patients included out of 150 selected undergoing BARS show a decrease in pain after CLIFE1 topical treatment (7.47 ± 13.09) greater than with CLIFE2 (4.38 ± 6.75), difference -3.21 95% CI (-5.75; -0.68), p = 0.008, decreasing significantly postoperative pain ( ≥ 9 mm, VAS) in 35% of patients undergoing benign anorectal surgery, compared to 18.33 % treated with lidocaine.
conclusionsThe CLIFE1 topical treatment shows better analgesic efficacy than CLIFE2 in BARS.
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