Efficacy of Duloxetine in pain after Hemorrhoid surgery

Efficacy of perioperative Duloxetine analgesia in posthemorrhoidectomy pain: prospective, randomized, double-blind, placebo-controlled study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-9pdgms

Enrollment

Unknown

Registered

2020-10-08

Start date

2019-04-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Hemorrhoid Disease, Acute Pain.

Interventions

Experimental Group: 27 patients undergoing hemorrhoidectomies, which precede the inclusion and exclusion criteria. Receive 1 tablet of Duloxetine 60mg orally, 2 hours before and 24 hours after hemorrh

Drug

Procedure/surgery

D02.886.778.260

HP3.073.433.101

E04.210.526

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ASA I and II patients; of both genders; age between 18 and 65 years; elective hemorrhoidectomy due to symptomatic hemorrhoidal disease. Patients who allow the use of their data for research activities after signing their Free and Informed Consent Terms (ICF) by them or a responsible family member.

Exclusion criteria

Exclusion criteria: Under 18 and over 65; renal or liver failure; history of drug or alcohol abuse; chronic pain or daily opioid intake; ASA III and IV patients; urgency / emergency surgery; pregnancy; psychiatric illness or cognitive disorders; known allergy to Duloxetine or the other drugs used in the study; coagulopathies; patients who refuse or have a contraindication to subarachnoid anesthesia.

Design outcomes

Primary

Measure	Time frame
Expected outcome 1 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 6 hours postoperatively.;Expected outcome 2 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 12 hours postoperatively.;Expected outcome 3 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 24 hours postoperatively.;Expected outcome 4 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 48 hours postoperatively.;Expected outcome 5 Pain reduction, verified by the visual analog scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement during the first evacuation.;Expected outcome 6 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 8th postoperative day.	—

Measure

Time frame

Expected outcome 1 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 6 hours postoperatively.;Expected outcome 2 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 12 hours postoperatively.;Expected outcome 3 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 24 hours postoperatively.;Expected outcome 4 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 48 hours postoperatively.;Expected outcome 5 Pain reduction, verified by the visual analog scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement during the first evacuation.;Expected outcome 6 Pain reduction, verified by the visual analogue scale (VAS), from the observation of a variation of at least 30% between the placebo group and the control in the measurement of the 8th postoperative day.

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Secondary

Measure	Time frame
Expected outcome 1 Decrease in the consumption of morphine, verified by the use of the intravenous pump (morphine 1mg / ml) with patient controlled analgesia, at 6 hours, 12 hours and 24 hours after surgery.;Expected outcome 2 Incidence of side effects possibly related to the use of duloxetine (dry mouth, nausea, vomiting, dizziness, visual disturbance, headache, etc.), verified through anamnesis and physical examination at 6 hours, 12 hours and 24 hours after surgery.	—

Measure

Time frame

Expected outcome 1 Decrease in the consumption of morphine, verified by the use of the intravenous pump (morphine 1mg / ml) with patient controlled analgesia, at 6 hours, 12 hours and 24 hours after surgery.;Expected outcome 2 Incidence of side effects possibly related to the use of duloxetine (dry mouth, nausea, vomiting, dizziness, visual disturbance, headache, etc.), verified through anamnesis and physical examination at 6 hours, 12 hours and 24 hours after surgery.

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Countries

Brazil

Contacts

Public ContactMarlus Gerber

Hospital Universitário Polydoro Ernani de São Thiago

marlusgerber@yahoo.com.br+5548996179553

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 10, 2026