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

NCT06606067 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: ICI21 / 000062022-001354-29
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Post-surgical Pain

Keywords

Chronic post-surgical pain; Duloxetine; Prevention; Hernia repair

Outcome Measures

Primary Outcomes (1)

• Efficacy of duloxetine versus placebo in reducing the incidence of Chronic Post-Surgical Pain (CPSP) at 4 months

  The primary outcome will be a change in the Chronic Post-Surgical Pain (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. Criteria of CPSP: 1) The pain develops after a surgical procedure or increases in intensity after the surgical procedure, 2) the pain should be of at least 3 months' duration and significantly affected the quality of life, 3) the pain is either a continuation of acute post-surgery pain or develops after an asymtomatic period, 4) the pain is either localized to the surgical field, projected to the innervation territory of a nerve situated in the surgical field, or referred to a dermatome, 5) other causes of the pain should be excluded: infection or continuing malignancy in cancer surgery.

  4 months after surgery

Secondary Outcomes (4)

• Characteristics of Chronic Post-Surgical Pain (CPSP)

  4 months after surgery

• Intensity of Pain

  4 months after surgery

• Quality of life in patients with Chronic Post-Surgical Pain (CPSP)

  4 months after surgery

• Adverse effects of perioperative duloxetine comparing with placebo

  2 weeks before surgery and 1 week after surgery

Study Arms (2)

Duloxetine

EXPERIMENTAL

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

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Duloxetine DRUG

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

Duloxetine

Placebo DRUG

Placebo tablet daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The score to establish risk for chronic post-surgical pain is validated only in men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Antonio Montes, PhD

  Hospital del Mar Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Duloxetine Placebo

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 20, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)