Chronic Post-surgical PainPhase 3GENDOLCAT3NCT06606067
Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk
A Phase 3 study testing Duloxetine in people with Chronic Post-surgical Pain, run by Parc de Salut Mar at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Post-surgical Pain
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteSpain
- Study dates
- 3 Sep 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Perioperative Duloxetine in Patients at High Risk for Developing Chronic Postsurgical Pain After Inguinal Hernia Repair: a Multicenter Randomized Controlled Trial.
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.
Read the 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
- Being tested
- Duloxetine, Placebo
- Keywords
- Chronic post-surgical pain, Duloxetine, Prevention, Hernia repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
30 mg daily 2 weeks before surgery and 1 week after surgery
PlaceboDrug
Placebo tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Participants received Duloxetine 30 mg / 24 h 2 weeks before surgery and 1 week after surgery Receives: Drug: Duloxetine |
| Placebo | Placebo comparator | Participants received Placebo / 24 h 2 weeks before surgery and 1 week after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months after surgery
Secondary outcomes (4)
Characteristics of Chronic Post-Surgical Pain (CPSP)
Compare the characteristics of Chronic Post-Surgical Pain (CPSP) in the intervention and control groups with neuropathic pain questionnaire (Douleur Neuropathique 4 (DN4 spanish version).
Measured: 4 months after surgery
Intensity of Pain
Compare the intensity characteristics of Chronic Post-Surgical Pain (CPSP) with Brief Pain Inventory-Short Form (BPI-SF).
Measured: 4 months after surgery
Quality of life in patients with Chronic Post-Surgical Pain (CPSP)
Compare the quality of life in the intervention and control groups with the SF-12 questionnaire (validated Spanish version 2)
Measured: 4 months after surgery
Adverse effects of perioperative duloxetine comparing with placebo
Comparing the rates of adverse effects of perioperative duloxetine and placebo for the primary prevention of Chronic Post-Surgical Pain (CPSP).
Measured: 2 weeks before surgery and 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start3 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-surgical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Duloxetine Placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Antonio Montes, PhD, Principal investigator, Hospital del Mar Research Institute (IMIM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606067
- Sponsor's protocol ID
- ICI21 / 00006
- Other IDs
- 2022-001354-29
- Acronym
- GENDOLCAT3
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Duloxetine in Patients at High Risk for Developing Chronic Postsurgical Pain After Inguinal Hernia Repair: a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06606067
- Acronym / sponsor ID
- GENDOLCAT3 / ICI21 / 00006
- Conditions
- Chronic Post-surgical Pain
- Keywords
- Chronic post-surgical pain, Duloxetine, Prevention, Hernia repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Duloxetine Placebo
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineParticipants received Duloxetine 30 mg / 24 h 2 weeks before surgery and 1 week after surgery |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received Placebo / 24 h 2 weeks before surgery and 1 week after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine30 mg daily 2 weeks before surgery and 1 week after surgery | Drug | Duloxetine |
| PlaceboPlacebo tablet daily | Drug | Placebo |
Primary outcome
Efficacy of duloxetine versus placebo in reducing the incidence of Chronic Post-Surgical Pain (CPSP) at 4 months
Time frame: 4 months after surgery
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 secondary outcomes
Characteristics of Chronic Post-Surgical Pain (CPSP)
Time frame: 4 months after surgery
Intensity of Pain
Time frame: 4 months after surgery
Quality of life in patients with Chronic Post-Surgical Pain (CPSP)
Time frame: 4 months after surgery
Adverse effects of perioperative duloxetine comparing with placebo
Time frame: 2 weeks before surgery and 1 week after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Montes, PhD principal investigator
Hospital del Mar Research Institute (IMIM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine in people with Chronic Post-surgical Pain, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of duloxetine versus placebo in reducing the incidence of Chronic Post-Surgical Pain (CPSP) at 4 months (time frame: 4 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.