Clinical trial NCT02328144: Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
Official title: Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhoids
Keywords: Hemorrhoidectomy
Postoperative pain
Metronidazole
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2014-12-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a difficult symptom to appreciate and assess, by its frequent and large variations in sensitivity in each patient. Many studies have been done to reduce patient postoperative pain, but there is no ideal method. The application of both oral and topical metronidazole has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.

The investigators evaluated the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy

Detailed description: Objective: Evaluate the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy.

Material and methods: Controlled clinical trial, composed of 44 patients in a randomized manner, realized at the Coloproctology, Western Medical Center, Mexican Institute of Social Security. Referred beneficiaries adults were included, of either sex, who merited elective hemorrhoidectomy for hemorrhoidal disease grades III-IV using Ferguson's technique. They were assigned to receive metronidazole (study group) or homologated (control group) and the randomization was conducted by sealed envelopes and subsequently. We collected demographic and clinical variables. Postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days; additional analgesic use; complications; return to normal activity and patient satisfaction; also were measured, in a blood sample after surgery and 12 hrs later, interleukin 6 and 10.

The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages

Eligibility criteria: Inclusion Criteria:

* Hemorrhoidal disease grade III and IV
* Informed consent

Exclusion Criteria:

* Pregnancy
* Lactation
* Other anorectal disease
* Previous anorectal
* hypersensibility to metronidazole

Primary outcomes:
measure: Pain evolution, hours and days after surgery
timeFrame: 6 and 12 hours, 1, 4, 7 and 14 days
Secondary outcomes:
measure: Interleukin
timeFrame: after surgery and 12 hours
measure: Analgesics
timeFrame: 6 and 12 hours, 1, 4, 7 and 14 days
measure: Surgery complications
timeFrame: 6 and 12 hours, 1, 4, 7 and 14 days
measure: Return to normal activities
timeFrame: 1, 4, 7 and 14 days
measure: Satisfaction
timeFrame: 14 day
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Western Medical Center, Mexican Institute of Social Security
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Clotilde Fuentes-Orozco, PhD
role: PRINCIPAL_INVESTIGATOR
References: