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Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

Information source: Centre Leon Berard
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatectomy; Pain; Metastasis

Intervention: Ropivacaine (Drug); Physiological serum (Drug)

Phase: N/A

Status: Completed

Sponsored by: Centre Leon Berard

Official(s) and/or principal investigator(s):
Véronique Peres-Bachelot, MD, Principal Investigator, Affiliation: Centre Leon Berard

Summary

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.

Clinical Details

Official title: A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption

Secondary outcome:

Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on daily morphine consumption

Evaluation of patients' perception of post-surgery pain

Immediate and late complications related to the perfusion, the medical device and other predictable side effects

Patients' post-surgery rehabilitation

Patients' satisfaction with the pain care

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Centre Léon Bérard, LYON Cedex 08 69373, France
Additional Information

Related publications:

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.

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):166-72, table of contents.

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.

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. French.

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Jalan R, Williams R, Bernuau J. Paracetamol: are therapeutic doses entirely safe? Lancet. 2006 Dec 23;368(9554):2195-6.

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Larson AM. Acetaminophen hepatotoxicity. Clin Liver Dis. 2007 Aug;11(3):525-48, vi. Review.

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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.

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.

Urwin SC, Smith HS. Fatal nefopam overdose. Br J Anaesth. 1999 Sep;83(3):501-2.

Villier C, Mallaret MP. Nefopam abuse. Ann Pharmacother. 2002 Oct;36(10):1564-6.

Ychou M, Viret F, Kramar A, Desseigne F, Mitry E, Guimbaud R, Delpero JR, Rivoire M, Quénet 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. Epub 2007 Sep 28.

Starting date: March 2009
Last updated: April 20, 2015

Page last updated: August 23, 2015

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