Abdominal Surgery by LaparotomyPhase 4LARANCT05368753
Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
A Phase 4 study testing Blood sample, Lidocain and ropivacaine in people with Abdominal Surgery by Laparotomy and Thoracic Epidural Analgesia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery by Laparotomy, Thoracic Epidural Analgesia, Analgesia
- What is being tested?
- Blood sample, Lidocain and ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2022to 2 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal surgery by laparotomy
Who cannot join
- laparoscopic abdominal surgery,
- TEA contraindication,
- ropivacaine contraindication
- intravenous lidocaine contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period.
Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery.
Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.
- Conditions
- Abdominal Surgery by Laparotomy, Thoracic Epidural Analgesia, Analgesia, Lidocaine Adverse Reaction
- Being tested
- Blood sample, Lidocain, ropivacaine
- Keywords
- Abdominal surgery by laparotomy, thoracic epidural analgesia, Analgesia, Lidocaine Adverse Reaction
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Lidocaine blood sample 30 min before the end of the surgery Lidocaine blood sample at the end of the infusion lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA Ropivacaine blood sample 24h after the infusion of the TEA
LidocainDrug
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end) The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.
ropivacaineDrug
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| thoracic epidural analgesia | Experimental | Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period Receives: Other: Blood sample; Drug: Lidocain; Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lidocaine concentration (micrograms/ml)
Lidocaine blood sample will be performed 30 min before the end of the surgery
Measured: 30 minutes before the end of surgery
blood lidocaine concentration (micrograms/ml)
lidocaine blood sample will be performed at the end of the infusion,
Measured: at the end of the surgery (assessed up to 2 hours)
blood lidocaine and ropivacaine concentration (micrograms/ml)
lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,
Measured: at 2 hours
blood ropivacaine concentration (micrograms/ml)
ropivacaine blood sample 24h after the infusion of the TEA
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start9 Mar 2022
- Primary completion28 Jan 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Surgery by LaparotomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368753
- Sponsor's protocol ID
- PI2021_843_0197
- Acronym
- LARA
- Status last verified
- Nov 2025
- First submitted
- 14 Mar 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trocheris-Fumery O, Pruvot A, Tarpin P, Collette S, Bodeau S, Diouf M, Regimbeau JM, Dupont H, Bar S, Bennis Y, Abou-Arab O. A prospective observational study of plasma concentrations and safety of combined intravenous lidocaine and epidural ropivacaine in laparotomy surgery. PLoS One. 2026 Mar 6;21(3):e0344277. doi: 10.1371/journal.pone.0344277. eCollection 2026.
PubMed 41790838
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05368753
- Acronym / sponsor ID
- LARA / PI2021_843_0197
- Conditions
- Abdominal Surgery by Laparotomy, Thoracic Epidural Analgesia, Analgesia, Lidocaine Adverse Reaction
- Keywords
- Abdominal surgery by laparotomy, thoracic epidural analgesia, Analgesia, Lidocaine Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 10 May 2022 (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.
Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period.
Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery.
Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic epidural analgesia | Experimental | Other: Blood sample, Drug: Lidocain, Drug: ropivacaineLidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abdominal surgery by laparotomy
Key exclusion criteria (4 listed)
- laparoscopic abdominal surgery,
- TEA contraindication,
- ropivacaine contraindication
- intravenous lidocaine contraindication
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 |
|---|---|---|
| Blood sampleLidocaine blood sample 30 min before the end of the surgery Lidocaine blood sample at the end of the infusion lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA Ropivacaine blood sample 24h after the infusion of the TEA | Other | thoracic epidural analgesia |
| LidocainLidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end) The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period. | Drug | thoracic epidural analgesia |
| ropivacaineLidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period. | Drug | thoracic epidural analgesia |
Primary outcome
Blood lidocaine concentration (micrograms/ml)
Time frame: 30 minutes before the end of surgery
Lidocaine blood sample will be performed 30 min before the end of the surgery
blood lidocaine concentration (micrograms/ml)
Time frame: at the end of the surgery (assessed up to 2 hours)
lidocaine blood sample will be performed at the end of the infusion,
blood lidocaine and ropivacaine concentration (micrograms/ml)
Time frame: at 2 hours
lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,
blood ropivacaine concentration (micrograms/ml)
Time frame: at 24 hours
ropivacaine blood sample 24h after the infusion of the TEA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 41790838Trocheris-Fumery O, Pruvot A, Tarpin P, Collette S, Bodeau S, Diouf M, Regimbeau JM, Dupont H, Bar S, Bennis Y, Abou-Arab O. A prospective observational study of plasma concentrations and safety of combined intravenous lidocaine and epidural ropivacaine in laparotomy surgery. PLoS One. 2026 Mar 6;21(3):e0344277. doi: 10.1371/journal.pone.0344277. eCollection 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood sample, Lidocain and ropivacaine in people with Abdominal Surgery by Laparotomy and Thoracic Epidural Analgesia, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 19 Nov 2025. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood lidocaine concentration (micrograms/ml) (time frame: 30 minutes before the end of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05368753, which also lists 1 linked publication.
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 19 Nov 2025.