Clinical trial · Interventional
Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations
A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management
NCT01194843CI-TRIAL-00017591DPOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the efficacy and impact on morphine consumption of ropivacaine administered by local per and post hepatic surgery infiltration. Patients will be randomized to either ropivacaine or physiological serum, with equivalent administration modalities in both arms. Patients will be followed during 4 days after the surgery. They will also come back for a follow-up visit one month later. It is necessary to enrol 100 patients. The estimated period of inclusion is 24 months. This is a prospective, comparative, monocentric, double-blind randomized study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatectomy | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physiological serum | Drug | — | UNRESOLVED |
| Ropivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ropivacaine
- description
- Ropivacaine administration by local per and post surgery infiltration
- interventionNames
- Drug: Ropivacaine
- type
- ACTIVE_COMPARATOR
- label
- Physiological serum
- description
- Administration of physiological serum by local per and post surgery infiltration
- interventionNames
- Drug: Physiological serum
Primary outcomes (1)
- measure
- Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients aged ≥ 18 years * Patients with histologically confirmed cancer * Patients treated at the Centre Léon Bérard * Patients requiring a surgery for hepatic metastases * ASA \<= 3 * At least 3 weeks between surgery and chemotherapy * Total bilirubin \< 1.5 x upper limit of normal range * ASAT and ALAT \< 5 times x upper limit of normal range * Creatinine clearance \> 60 ml per hour * Serum creatinine \< 115 µmol/l * Mandatory affiliation with a health insurance system * Patients able to understand French * Signed, written informed consent Exclusion Criteria: * Patients with a hepatocellular carcinoma or an initial liver cancer * Patients treated chronically by morphine * Patients that already have abdominal pain * Patients who are allergic either to morphinics, local anesthesics, paracetamol, NSAID or cortisone * Patients suffering from heart, kidney or liver insufficiency * Documented history of cognitive or psychiatric disorders * Pregnant or lactating women * Difficult follow-up
References
Publications (16)
- BACKGROUNDBeaussier M, El'Ayoubi H, Schiffer E, Rollin M, Parc Y, Mazoit JX, Azizi L, Gervaz P, Rohr S, Biermann C, Lienhart A, Eledjam JJ. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study. Anesthesiology. 2007 Sep;107(3):461-8. doi: 10.1097/01.anes.0000278903.91986.19. PMID 17721249
- BACKGROUNDBianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B, Guberti A, Massari L. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004 Jan;98(1):166-172. doi: 10.1213/01.ANE.0000093310.47375.44. PMID 14693613
- BACKGROUNDBorromeo CJ, Stix MS, Lally A, Pomfret EA. Epidural catheter and increased prothrombin time after right lobe hepatectomy for living donor transplantation. Anesth Analg. 2000 Nov;91(5):1139-41. doi: 10.1097/00000539-200011000-00018. PMID 11049898
- BACKGROUNDGodier A, Babinet A, el Metaoua S, Fulgencio JP, Bonnet F. [A new cause of postoperative confusion syndrome: nefopam]. Ann Fr Anesth Reanim. 2002 Jun;21(6):538-9. doi: 10.1016/s0750-7658(02)00650-0. French. PMID 12134601
- BACKGROUNDHo AM, Lee A, Karmakar MK, Samy W, Lai PB, Ho OA, Cho A. Hemostatic parameters after hepatectomy for cancer. Hepatogastroenterology. 2007 Jul-Aug;54(77):1494-8. PMID 17708283
- BACKGROUNDJalan R, Williams R, Bernuau J. Paracetamol: are therapeutic doses entirely safe? Lancet. 2006 Dec 23;368(9554):2195-6. doi: 10.1016/S0140-6736(06)69874-7. No abstract available. PMID 17189017
- BACKGROUNDKwan AL. Epidural analgesia for patient undergoing hepatectomy. Anaesth Intensive Care. 2003 Apr;31(2):236-7. No abstract available. PMID 12712800