Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations
NCT ID: NCT01194843
Last Updated: 2015-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2009-03-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Ropivacaine
Ropivacaine administration by local per and post surgery infiltration
Ropivacaine
40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy
Physiological serum
Administration of physiological serum by local per and post surgery infiltration
Physiological serum
40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy
Interventions
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Ropivacaine
40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy
Physiological serum
40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Fondation Apicil
OTHER
Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Véronique Peres-Bachelot, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Léon Bérard
Lyon, , France
Countries
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References
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Beaussier 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.
Bianconi 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.
Borromeo 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.
Godier 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.
Ho 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.
Jalan 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.
Kwan AL. Epidural analgesia for patient undergoing hepatectomy. Anaesth Intensive Care. 2003 Apr;31(2):236-7. No abstract available.
Larson AM. Acetaminophen hepatotoxicity. Clin Liver Dis. 2007 Aug;11(3):525-48, vi. doi: 10.1016/j.cld.2007.06.006.
Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.
Mazoit JX, Butscher K, Samii K. Morphine in postoperative patients: pharmacokinetics and pharmacodynamics of metabolites. Anesth Analg. 2007 Jul;105(1):70-8. doi: 10.1213/01.ane.0000265557.73688.32.
Murphy EJ. Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Anaesth Intensive Care. 2005 Jun;33(3):311-22. doi: 10.1177/0310057X0503300306.
Schumann R, Zabala L, Angelis M, Bonney I, Tighiouart H, Carr DB. Altered hematologic profiles following donor right hepatectomy and implications for perioperative analgesic management. Liver Transpl. 2004 Mar;10(3):363-8. doi: 10.1002/lt.20059.
Tsui SL, Yong BH, Ng KF, Yuen TS, Li CC, Chui KY. Delayed epidural catheter removal: the impact of postoperative coagulopathy. Anaesth Intensive Care. 2004 Oct;32(5):630-6. doi: 10.1177/0310057X0403200503.
Urwin SC, Smith HS. Fatal nefopam overdose. Br J Anaesth. 1999 Sep;83(3):501-2. doi: 10.1093/bja/83.3.501.
Villier C, Mallaret MP. Nefopam abuse. Ann Pharmacother. 2002 Oct;36(10):1564-6. doi: 10.1345/aph.1C017.
Ychou M, Viret F, Kramar A, Desseigne F, Mitry E, Guimbaud R, Delpero JR, Rivoire M, Quenet F, Portier G, Nordlinger B. Tritherapy with fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in colorectal cancer patients with non-resectable liver metastases. Cancer Chemother Pharmacol. 2008 Jul;62(2):195-201. doi: 10.1007/s00280-007-0588-3. Epub 2007 Sep 28.
Other Identifiers
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ET2007-073
Identifier Type: REGISTRY
Identifier Source: secondary_id
2007-007968-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DPO-Hepatectomy
Identifier Type: -
Identifier Source: org_study_id
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