NCT01194843

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

January 1, 2014

Enrollment Period

4.9 years

First QC Date

September 2, 2010

Last Update Submit

April 20, 2015

Conditions

HepatectomyPainMetastasis

Outcome Measures

Primary Outcomes (1)

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

    In the 4 days following the hepatectomy

Secondary Outcomes (5)

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

    In the 4 days following the hepatectomy

  • Evaluation of patients' perception of post-surgery pain

    In the 4 days following the hepatectomy

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

    In the 4 days following the hepatectomy and one month later

  • Patients' post-surgery rehabilitation

    Between surgery and follow-up visit, one month later

  • Patients' satisfaction with the pain care

    Four days after the hepatectomy

Study Arms (2)

Ropivacaine

EXPERIMENTAL

Ropivacaine administration by local per and post surgery infiltration

Drug: Ropivacaine

Physiological serum

ACTIVE COMPARATOR

Administration of physiological serum by local per and post surgery infiltration

Drug: Physiological serum

Interventions

RopivacaineDRUG

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

Ropivacaine
Physiological serumDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

Related Publications (16)

  • 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.

    PMID: 17721249BACKGROUND

  • 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.

    PMID: 14693613BACKGROUND

  • 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.

    PMID: 11049898BACKGROUND

  • 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.

    PMID: 12134601BACKGROUND

  • 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.

    PMID: 17708283BACKGROUND

  • 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.

    PMID: 17189017BACKGROUND

  • Kwan AL. Epidural analgesia for patient undergoing hepatectomy. Anaesth Intensive Care. 2003 Apr;31(2):236-7. No abstract available.

    PMID: 12712800BACKGROUND

  • Larson AM. Acetaminophen hepatotoxicity. Clin Liver Dis. 2007 Aug;11(3):525-48, vi. doi: 10.1016/j.cld.2007.06.006.

    PMID: 17723918BACKGROUND

  • 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.

    PMID: 17116561BACKGROUND

  • 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.

    PMID: 17578959BACKGROUND

  • 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.

    PMID: 15973913BACKGROUND

  • 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.

    PMID: 15004762BACKGROUND

  • 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.

    PMID: 15535484BACKGROUND

  • Urwin SC, Smith HS. Fatal nefopam overdose. Br J Anaesth. 1999 Sep;83(3):501-2. doi: 10.1093/bja/83.3.501.

    PMID: 10655934BACKGROUND

  • Villier C, Mallaret MP. Nefopam abuse. Ann Pharmacother. 2002 Oct;36(10):1564-6. doi: 10.1345/aph.1C017.

    PMID: 12243607BACKGROUND

  • 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.

    PMID: 17901955BACKGROUND

MeSH Terms

Conditions

PainNeoplasm Metastasis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasmsPathologic Processes

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Véronique Peres-Bachelot, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 3, 2010

Study Start

March 1, 2009

Primary Completion

February 1, 2014

Study Completion

April 1, 2015

Last Updated

April 21, 2015

Record last verified: 2014-01

Locations

FR(1)