Chronic PainPhase 3LIDOC-POPEYENCT07869173
"Evaluation of the Efficacy of Intravenous Lidocaine on Chronic Post-operative Pain in Patients Requiring Emergency Abdominal Surgery. A Multicentre, Randomised, Controlled, Double-blind Study."
A Phase 3 study testing Lidocain in people with Chronic Pain, run by Nantes University Hospital at 6 sites in France.
Trial summary
Chronic pain is a major public health issue. According to the most recent sources, it affects around 11 million people in France, leading to a significant deterioration in patients' quality of life, limitations in their activities of daily living, and an impact on their mental health (anxiety and depression symptoms). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 6 sitesFrance
- Study dates
- 15 Jan 2027to 15 Jul 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 and under 80
- Emergency or semi-emergency abdominal surgery of the following types:
- Urological Gastrointestinal Gynaecological
- Open or laparoscopic surgery
- Estimated duration of surgery ≥ 60 minutes
Who cannot join
- Use of a regional anaesthesia technique involving epidural analgesia
- Surgery as part of a transplant procedure
- High-degree atrioventricular block without a pacemaker, chronic treatment with class I antiarrhythmic drugs
- Shock defined as a systolic blood pressure ≤ 90 mmHg on admission to the emergency operating theatre
- Respiratory failure defined as a respiratory rate > 25 breaths per minute and/or a transcutaneous oxygen saturation < 90% on admission to the emergency operating theatre
- Neurological impairment defined as a Glasgow Coma Scale score ≤ 13 on admission to the emergency operating theatre
Show all 11Show fewer
- Known dementia
- Patients who are active drug users or undergoing withdrawal, given the significant difficulties in managing perioperative analgesia in these patients [65]
- Pregnancy or breastfeeding. Women of childbearing age will undergo a pregnancy test prior to inclusion.
- Porphyria
- Contrai indications to lidocaine:
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
CHU Angers
Angers, 49933
Lasocki SIGISMOND, PhD, sigismond@lasocki.com
CHU Brest
Brest
Charlotte RAIMBAULT, charlotte.raimbault@chu-brest.fr
CHD Vendée
La Roche-sur-Yon
Alexis DUCHALAIS, alexis.duchalais@chd-vendee.fr
Chu Nantes
Nantes, 44093
Raphaël CINOTTI, PhD, raphael.cinotti@chu-nantes.fr
CHU Rennes
Rennes, 35000
Hélène BELOEIL, PhD, helene.beloeil@chu-rennes.fr
CHU Toulouse
Toulouse, 31059
Guillaume PORTA BONETE, porta-bonete.g@chu-toulouse.fr
About this study
Chronic pain is a major public health issue. According to the most recent sources, it affects around 11 million people in France, leading to a significant deterioration in patients' quality of life, limitations in their activities of daily living, and an impact on their mental health (anxiety and depression symptoms). Furthermore, chronic pain imposes a significant economic cost on society.
In France, it is estimated that 10 million surgical or interventional procedures are carried out each year. However, the most recent epidemiological data suggest that 20 to 30 per cent of patients will experience chronic post-surgical pain (CPSP) within 3 to 6 months following the procedure. It is therefore essential to improve perioperative care in order to reduce patients' CSPS: this would bring major benefits at both the individual and societal levels. Lidocaine is a local anaesthetic that has been widely used in human clinical practice for decades in the management of acute pain. Evidence also suggests that its use as a continuous intravenous infusion may have a beneficial effect on post-operative pain and reduce its incidence, but there are no guidelines regarding the use of lidocaine in this context. It therefore seems necessary to evaluate the efficacy of intravenous lidocaine on post-operative pain.
The Investigators propose to evaluate the efficacy of intravenous lidocaine on post-operative pain in a large-scale, multicentre, randomised, placebo-controlled trial (266 patients) involving patients requiring emergency abdominal surgery, a population at high risk of post-operative pain that has been little studied in the literature. In this study, we will assess the impact of post-operative pain on patients' quality of life and mental health.
- Conditions
- Chronic Pain
- Being tested
- Lidocain, Placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocainDrug
The investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of lidocaine and then starts an infusion of 1.5 mg/kg/h of lidocaine (based on the patient's theoretical ideal weight)
PlaceboDrug
The investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of placebo, and then starts an infusion of 1.5 mg/kg/h of placebo (based on the patient's theoretical ideal weight)
| Study group | Role | What they receive |
|---|---|---|
| Experimental : lidocaïne | Experimental | The investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of lidocaine , and then starts an infusion of 1.5 mg/kg/h of lidocaine (based on the patient's theoretical ideal weight) Receives: Drug: Lidocain |
| Placebo | Placebo comparator | The investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of placebo, and then starts an infusion of 1.5 mg/kg/h of placebo (based on the patient's theoretical ideal weight) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-surgical pain
Chronic post-surgical pain is defined as pain with an intensity of ≥ 4 on a Simple Numerical Scale 6 months after surgery.
Measured: 6 months
Secondary outcomes (2)
effectiveness of the intervention
The effectiveness of the intervention will be assessed using:
- The Brief Pain Inventory (BPI) at 3 months after randomisation
- Intake of paracetamol, non-steroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors (duloxetine, venlafaxine) and gabapentinoids (gabalin, pre-gabalin) in the Post-Interventional Monitoring Unit, on discharge from hospital, and at 3 months (prescribed doses).
- Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 3 months
Measured: 3 months
effectiveness of the intervention
The effectiveness of the intervention will be assessed using:
- The Brief Pain Inventory (BPI) at 6 months after randomisation
- Intake of paracetamol, non-steroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors (duloxetine, venlafaxine) and gabapentinoids (gabalin, pre-gabalin) in the Post-Interventional Monitoring Unit, on discharge from hospital, at 6 months (prescribed doses).
- Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869173
- Sponsor's protocol ID
- RC25_0291
- Acronym
- LIDOC-POPEYE
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of the Efficacy of Intravenous Lidocaine on Chronic Post-operative Pain in Patients Requiring Emergency Abdominal Surgery. A Multicentre, Randomised, Controlled, Double-blind Study."
- ClinicalTrials.gov ID
- NCT07869173
- Acronym / sponsor ID
- LIDOC-POPEYE / RC25_0291
- Conditions
- Chronic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 9 Oct 2026 (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.
Chronic pain is a major public health issue. According to the most recent sources, it affects around 11 million people in France, leading to a significant deterioration in patients' quality of life, limitations in their activities of daily living, and an impact on their mental health (anxiety and depression symptoms). Furthermore, chronic pain imposes a significant economic cost on society.
In France, it is estimated that 10 million surgical or interventional procedures are carried out each year. However, the most recent epidemiological data suggest that 20 to 30 per cent of patients will experience chronic post-surgical pain (CPSP) within 3 to 6 months following the procedure. It is therefore essential to improve perioperative care in order to reduce patients' CSPS: this would bring major benefits at both the individual and societal levels. Lidocaine is a local anaesthetic that has been widely used in human clinical practice for decades in the management of acute pain. Evidence also suggests that its use as a continuous intravenous infusion may have a beneficial effect on post-operative pain and reduce its incidence, but there are no guidelines regarding the use of lidocaine in this context. It therefore seems necessary to evaluate the efficacy of intravenous lidocaine on post-operative pain.
The Investigators propose to evaluate the efficacy of intravenous lidocaine on post-operative pain in a large-scale, multicentre, randomised, placebo-controlled trial (266 patients) involving patients requiring emergency abdominal surgery, a population at high risk of post-operative pain that has been little studied in the literature. In this study, we will assess the impact of post-operative pain on patients' quality of life and mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : lidocaïne | Experimental | Drug: LidocainThe investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of lidocaine , and then starts an infusion of 1.5 mg/kg/h of lidocaine (based on the patient's theoretical ideal weight) |
| Placebo | Placebo comparator | Drug: PlaceboThe investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of placebo, and then starts an infusion of 1.5 mg/kg/h of placebo (based on the patient's theoretical ideal weight) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged over 18 and under 80
- Emergency or semi-emergency abdominal surgery of the following types:
- Urological Gastrointestinal Gynaecological
- Open or laparoscopic surgery
- Estimated duration of surgery ≥ 60 minutes
Key exclusion criteria (11 listed)
- Use of a regional anaesthesia technique involving epidural analgesia
- Surgery as part of a transplant procedure
- High-degree atrioventricular block without a pacemaker, chronic treatment with class I antiarrhythmic drugs
- Shock defined as a systolic blood pressure ≤ 90 mmHg on admission to the emergency operating theatre
- Respiratory failure defined as a respiratory rate > 25 breaths per minute and/or a transcutaneous oxygen saturation < 90% on admission to the emergency operating theatre
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 |
|---|---|---|
| LidocainThe investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of lidocaine and then starts an infusion of 1.5 mg/kg/h of lidocaine (based on the patient's theoretical ideal weight) | Drug | Experimental : lidocaïne |
| PlaceboThe investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of placebo, and then starts an infusion of 1.5 mg/kg/h of placebo (based on the patient's theoretical ideal weight) | Drug | Placebo |
Primary outcome
Chronic post-surgical pain
Time frame: 6 months
Chronic post-surgical pain is defined as pain with an intensity of ≥ 4 on a Simple Numerical Scale 6 months after surgery.
2 secondary outcomes
effectiveness of the intervention
Time frame: 3 months
effectiveness of the intervention
Time frame: 6 months
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 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocain in people with Chronic Pain, run by Nantes University Hospital at 6 sites in France.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Contact Raphaël CINOTTI PhD (0240084731, raphael.cinotti@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic post-surgical pain (time frame: 6 months). 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 9 Oct 2026.