Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
182
Countries
1
Sites
1
colorectal cancer laparoscopic surgery
Evaluate the effectiveness of combining intravenous lidocaine and ropivacaine infiltration of laparoscopic trocar sites on postoperative recovery as assessed using the QOR-15 twenty-four hours after colorectal surgery.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 24 Apr 2026 → ongoing
- Decision date (initial)
- 2025-12-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluate the effectiveness of combining intravenous lidocaine and ropivacaine infiltration of laparoscopic trocar sites on postoperative recovery as assessed using the QOR-15 twenty-four hours after colorectal surgery.
Secondary objectives 12
- Assess the safety of this combination in terms of concentration, accumulation, and tolerance
- Assess postoperative recovery using the QOR-15 at patient discharge
- Assess postoperative pain at rest and during mobilization during the first 48 hours
- Assess the amount of morphine received intraoperatively
- Assess analgesic consumption, particularly the amount of opioids received in the 48 hours following surgery
- Assess the occurrence of dysesthesia (peri-scar hyperalgesia, allodynia, numbness) at the surgical site at 48 hours
- Assess the occurrence of persistent nociceptive and neuropathic pain at the surgical site at 3 months
- Assess the time before bowel function resumes and food tolerance
- Assess surgical complications using the Clavien Dindo score during the post-operative consultation (carried out 1 month after surgery)
- Assess whether the patient's general condition allows for postoperative chemotherapy if indicated by the oncology multidisciplinary team (conducted after pathological analysis of the surgical specimen)
- Assess length of stay.
- Assess patient satisfaction (EVAN score) upon discharge
Conditions and MedDRA coding
colorectal cancer laparoscopic surgery
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | avec lidocaine VS sans lidocaine Il s’agit d’un essai contrôlé randomisé en simple aveugle monocentrique. Les patients randomisés en deux groupes avec stratification selon la localisation de la chirurgie : colorectale ou colique seule.
|
Randomised Controlled | Single | [{"id":155520,"code":1,"name":"Subject"}] | Standard Arm: Sans lidocaine Experimental Arm: Avec lidocaine |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients undergoing scheduled laparoscopic colorectal cancer surgery.
- Patients aged 18 years or older
- Highly effective method of contraception for women of childbearing age (combined hormonal contraception (estrogen and progesterone) combined with ovulation inhibition (oral, intravaginal, transdermal), hormonal contraception (progesterone only) combined with ovulation inhibition (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral fallopian tube occlusion, vasectomized partner, sexual abstinence.
- Informed consent and signed agreement
- Enrollment in a Social Security plan
Exclusion criteria 10
- Allergy or contraindication to lidocaine or ropivacaine,
- Allergy or contraindication to paracetamol, nefopam, ketamine, propofol, dexamethasone, sufentanil , Celebrex or Parecoxib, , morphine derivatives, and Colorectal surgery by laparotomy
- Colorectal surgery by laparotomy
- Colorectal surgery not indicated for cancer treatment
- Chronic preoperative pain (defined as pain persisting for more than 3 months),
- Preoperative use of opioids or opioid derivatives,
- Patients suffering from psychiatric disorders
- Patients for whom pain self-assessment using a self-assessment scale cannot be performed (non-communicative, non-English-speaking, etc.)
- Pregnant or breastfeeding women
- Patients under guardianship, conservatorship, or legal protection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Postoperative recovery assessed using the QOR-15 scale twenty-four hours after surgery.
Secondary endpoints 13
- Assessment of plasma concentrations of lidocaine (toxic threshold >5 µg/mL) and ropivacaine (toxic threshold >2.2 µg/mL)
- Signs of local anesthetic toxicity sought in the post-anesthesia care unit (PACU) for up to two hours after the end of the procedure: o Cardiological (conduction disorders, atrioventricular conduction disorders, rhythm disorders, especially ventricular: ventricular tachycardia, ventricular fibrillation, or even cardiac arrest in asystole) o Neurological (perioral tingling, headaches, visual or auditory distortions, tremors in the extremities, loss of consciousness, coma, convulsions)
- Postoperative pain assessed using the numerical rating scale (NRS) at H2 at rest, H24 at rest and during mobilization, H48 at rest and during mobilization
- Maximum pain assessed using the NRS during the first 48 hours
- Postoperative analgesic consumption during the first 48 hours
- Consumption of morphine derivatives expressed in oral morphine equivalent (mg) per operation and 48 hours post-operatively
- Occurrence of dysesthesia (peri-scar hyperalgesia, allodynia, numbness) at the surgical site at 48 hours
- Neuropathic pain, defined as a DN4 score > 4/10 at 48 hours and 3 months
- The time before resumption of transit (resumption of gas and then bowel movements) and food tolerance will be assessed through daily interviews with the physician.
- Medical and surgical complications will be assessed using the Clavien Dindo score one month after surgery.
- Possibility of chemotherapy within two months post-op if indicated by the oncology multidisciplinary team meeting
- Length of stay from admission to discharge, expressed in days
- Patient satisfaction, assessed using the EVANS score upon discharge
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
XYLOCARD 20 mg/ml INTRAVEINEUX, solution injectable
PRD4875565 · Product
- Active substance
- Anhydrous Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 2 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 2 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01BB01 — LIDOCAINE
- Marketing authorisation
- 6 552 859 3
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 11
NEFOPAM BIOGARAN 20 mg/2 mL, solution injectable
PRD3944826 · Product
- Active substance
- Nefopam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BG06 — NEFOPAM
- Marketing authorisation
- 34009 300 395 4 0
- MA holder
- BIOCODEX
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUFENTANIL KALCEKS 5 microgrammes/mL, solution injectable/pour perfusion
PRD10211501 · Product
- Active substance
- Sufentanil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 0.2 µg/Kg microgram(s)/kilogram
- Max total dose
- 0.2 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- 34009 550 934 8 0
- MA holder
- KALCEKS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paracetamol 10 mg/ml Solution for Infusion
PRD1607761 · Product
- Active substance
- Paracetamol
- Substance synonyms
- ACETAMINOPHEN
- Pharmaceutical form
- INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 4 g gram(s)
- Max total dose
- 12 g gram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- PL 04416/1388
- MA holder
- SANDOZ LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ROPIVACAINE B.BRAUN 2 mg/ml, solution injectable/pour perfusion
PRD4942725 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFILTRATION
- Max daily dose
- 2 mg/ml milligram(s)/millilitre
- Max total dose
- 20 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 34009 579 574 8 3
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3040293 · Product
- Active substance
- Morphine Sulfate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 280 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 34009 349 510 8 4
- MA holder
- ETHYPHARM
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DEXAMETHASONE KRKA 8 mg/2 ml, solution injectable/pour perfusion
PRD8035166 · Product
- Active substance
- Dexamethasone Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 8 mg milligram(s)
- Max total dose
- 8 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 34009 302 043 7 5
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Parecoxib Seacross 40 mg powder for solution for injection
PRD12086900 · Product
- Active substance
- Parecoxib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AH04 — PARECOXIB
- Marketing authorisation
- PL 41013/0070
- MA holder
- SEACROSS PHARMACEUTICALS LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KETAMINE G.L. PHARMA 10 mg/mL, solution injectable
PRD11493787 · Product
- Active substance
- Ketamine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 0.5 mg/Kg milligram(s)/kilogram
- Max total dose
- 0.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX03 — KETAMINE
- Marketing authorisation
- 6 461 384 5
- MA holder
- G.L. PHARMA GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Propofol Kabi 10 mg/ml emulsion for injection or infusion
PRD12085686 · Product
- Active substance
- Propofol
- Substance synonyms
- 2,6-Bis(PROPAN-2-YL)PHENOL, ICI-35868, DISOPROFOL
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2 mg/Kg milligram(s)/kilogram
- Max total dose
- 2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- AA1123/00201
- MA holder
- FRESENIUS KABI ITALIA S.R.L.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD945133 · Product
- Active substance
- Nefopam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BG06 — NEFOPAM
- Marketing authorisation
- 34009 324 217 5 6
- MA holder
- BIOCODEX
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10017496 · Product
- Active substance
- Celecoxib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AH01 — CELECOXIB
- Marketing authorisation
- 10007/2017/02
- MA holder
- UPJOHN EESV
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Ottilie Trocheris - Fumery
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Ottilie Trocheris - Fumery
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 182 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Amiens Picardie
Département d’Anesthésie-Réanimation, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-04-24 | 2026-04-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-523207-29-00 | 1.2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lidocaine 20 mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis-2025-523207-29-00 | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-15 | France | Acceptable 2025-12-12
|
2025-12-17 |