Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk

NCT ID: NCT06606067

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2026-12-31

Brief Summary

The clinical trial will be conducted in 14 Spanish hospitals. It is estimated, based on our previous studies, that 2855 patients scheduled for elective inguinal hernia surgery will have to be assessed to detect patients with ≥ 27% level of risk for Chronic Post-Surgical Pain (CPSP). These high-risk patients will be randomized to 2 treatment groups: one will receive duloxetine for 2 weeks prior to surgery and 1 week after surgery (intervention group) and the other the placebo (control group) during the same periods. The primary outcome will be a ≥ 50% decrease in the CPSP incidence in the intervention group compared to the placebo group, 4 months after surgery.

Detailed Description

Prospective, multicenter, double-blind randomized double-blind controlled trial. In the first phase the investigators use the Chronic Post-Surgical Pain (CPSP) risk model to select patients scheduled for inguinal hernia repair with a ≥27% level of risk for CPSP.

A total of 2855 patients will be screened in 14 Spanish hospitals (Hospital del Mar (Barcelona) / Hospital Germans Trias i Pujol (Badalona) / H Vall d'Hebrón (Barcelona) / Hospital de Bellvitge (Barcelona) / Hospital de Cruces (Bilbao) / Hospital 12 de Octubre (Madrid) / Hospital de Valme (Sevilla) / Hospital de Son Espases (Palma de Mallorca) / Hospital Son Llatzer (Palma de Mallorca) / Hospital General de Valladolid (Valladolid)/ Hospital General de Alicante (Alicante)/ Hospital Lluís Alcanyís de Xativa).

The high-risk patients will be randomized to 2 treatment groups to receive 30 mg/d of duloxetine for 2 weeks prior to surgery and 1 week after surgery (intervention group) or placebo (control group) during the same periods.

The primary outcome will be a decrease in the CPSP incidence at 4 months in the intervention group compared to the placebo group with an odds ratio of 0.44 as the effect size. The investigators estimate that it will be necessary to treat 294 participants (147 in each group). Participants that might have CPSP will be detected in follow-up telephone interviews approximately 3 months after surgery. Participants who report pain at that time will be scheduled for an appointment at their hospital's pain clinic to confirm the CPSP diagnosis by exhaustive physical examination and to assess pain intensity, characteristics, and degree of interference with daily living.

Conditions

Chronic Post-surgical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Duloxetine

Participants received Duloxetine 30 mg / 24 h 2 weeks before surgery and 1 week after surgery

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

30 mg daily 2 weeks before surgery and 1 week after surgery

Placebo

Participants received Placebo / 24 h 2 weeks before surgery and 1 week after surgery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet daily

Interventions

Duloxetine

30 mg daily 2 weeks before surgery and 1 week after surgery

Intervention Type: DRUG

Placebo

Placebo tablet daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men resident in Spain who are scheduled for open inguinal hernia repair (inpatient or outpatient procedures).
• Risk of post-surgical pain chronification > 27% using the GENDOLCAT risk scale.

Exclusion Criteria

• Age under 18 years
• Patients who in the recruiter's opinion have insufficient knowledge of Spanish to understand the trial
• Patients who are currently being treated with duloxetine
• Patents with known allergy to duloxetine
• Serious renal failure (creatinine clearance >30 ml/min)
• Patients requiring reoperation because of surgical complications
• Transplanted patients
• History of coronary artery disease, including previous myocardial infarction, angina, percutaneous transluminal coronary angioplasty
• History of congestive heart failure
• Currently taking a monoamine oxidase inhibitor or other medication with substantial interaction with duloxetine
• Antidepressant use within 4 weeks of study start
• Treatment with inhibitors of cytochrome P450 mixed-function oxidase system (CYP1A2): fluvoxamine, ciprofloxacin or enoxacin
• Uncontrolled hypertension
• Bipolar disorder
• History of seizures
• Elevated intraocular pressure or risk of acute glaucoma
• Treatment with selective serotonin reuptake inhibitors (SSRIs)
• Treatment with serotonin and noradrenaline reuptake inhibitors (SNRIs)
• Treatment with tricyclic antidepressants
• Treatment with triptans
• Treatment with antipsychotic drugs
• Treatment with dopamine antagonists
• Treatment with oral anticoagulant agents
• Treatment with Hypericum perforatum
• Major depression disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Carlos III Health Institute

OTHER_GOV

Sponsor Role: collaborator

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Montes, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar Research Institute

Locations

Hospital del Mar

Barcelona, , Spain

Countries

Spain

Other Identifiers

2022-001354-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ICI21 / 00006

Identifier Type: -

Identifier Source: org_study_id