Evidence map›Paper›PMID 20100408›Full record

Trial reportCanadian journal of surgery. Journal canadien de chirurgie2010

Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study.

Pasquale Perrotti, Patrizia Dominici, Enzo Grossi, Renata Cerutti, Carmine Antropoli

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC
In one paragraph

Trial report in Canadian journal of surgery. Journal canadien de chirurgie, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07659665 (The Effect of Oral Nifedipine Versus Placebo on Postoperative Pain and Healing Following Hemorrhoidectomy in Adult Patients), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT07659665 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

The Effect of Oral Nifedipine Versus Placebo on Postoperative Pain and Healing Following Hemorrhoidectomy in Adult Patients: A Randomized Controlled Trial in Sana'a, Yemen

TypeinterventionalSponsorSana'a UniversityRan2026 to 2026Enrolled100ConditionsHemorrhoids, Postoperative Pain, Wound Healing, AnalgesiaArmsNifedipine 20 Mg, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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  5. Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Pasquale PerrottiChirurgia Gastroenterologica, Department of Gastroenterology, A. Cardarelli Hospital, Naples, Italy. pasper1@alice.it
Patrizia Dominici
Enzo Grossi
Renata Cerutti
Carmine Antropoli
Fatebenefratelli Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSpasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy, a common and distressing experience. We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter.

methodsWe conducted a multicentre randomized, double-blind trial to compare the efficacy of 0.3% nifedipine and 1.5% lidocaine ointment versus 1.5% lidocaine ointment alone in reducing pain after hemorrhoidectomy. A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale (ACCS) at baseline; soon after surgery; at 2, 4, 6, 8 and 24 hours after surgery; on day 7 after surgery; and at a final visit 14 days after surgery. The physician also noted the time to first analgesic administration within 24 hours after surgery.

resultsIn all, 135 patients per group participated (270 total). Evaluation of the delta ACCS score versus basal value, a covariate for rescue analgesic administration time, revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 (p < 0.011 and p < 0.054, respectively). We noticed no difference between groups for time of administration of rescue analgesic, blood pressure, heart rate or frequency of headache.

conclusionAlthough there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy, the patients' assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery. Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended. Further research focusing on these outcomes is warranted.

Indexed as

AdultAnesthetics, LocalCalcium Channel BlockersDouble-Blind MethodDrug CombinationsFemaleHemorrhoidsHumansLidocaineMaleMiddle AgedNifedipineOintmentsPostoperative PainProspective StudiesAnesthetics, LocalAntrolinCalcium Channel BlockersDrug CombinationsLidocaineNifedipineOintments

Identifiers

PMID20100408
PMCPMC2810010
OpenAlexW2099124163

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.