AzTrials
AzTrials

HepatectomyDPONCT01194843

Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

A study testing Ropivacaine and Physiological serum in people with Hepatectomy and Pain, run by Centre Leon Berard at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatectomy, Pain, Metastasis
What is being tested?
Ropivacaine and Physiological serum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteFrance
Study dates
Mar 2009to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Léon Bérard

    Lyon, 69373

Other trials in France

About this study

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

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.

Being tested
Ropivacaine, Physiological serum
Medical subject headings
Pain, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT01194843
Study groupRoleWhat they receive
RopivacaineExperimentalRopivacaine administration by local per and post surgery infiltration
Receives: Drug: Ropivacaine
Physiological serumActive comparatorAdministration of physiological serum by local per and post surgery infiltration
Receives: Drug: Physiological serum

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: In the 4 days following the hepatectomy

Secondary outcomes (5)

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

    Measured: In the 4 days following the hepatectomy

  2. Evaluation of patients' perception of post-surgery pain

    Measured: In the 4 days following the hepatectomy

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

    Measured: In the 4 days following the hepatectomy and one month later

  4. Patients' post-surgery rehabilitation

    Measured: Between surgery and follow-up visit, one month later

  5. Patients' satisfaction with the pain care

    Measured: Four days after the hepatectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2010 (estimated)
  2. Study startMar 2009
  3. Primary completionFeb 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01194843
Sponsor's protocol ID
DPO-Hepatectomy
Other IDs
ET2007-073, 2007-007968-19
Acronym
DPO
Status last verified
Jan 2014
First submitted
2 Sep 2010
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
No

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. doi: 10.1097/01.anes.0000278903.91986.19.

    PubMed 17721249

  • 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.

    PubMed 14693613

  • 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.

    PubMed 11049898

  • 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.

    PubMed 12134601

  • 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.

    PubMed 17708283

  • 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.

    PubMed 17189017

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

    PubMed 12712800

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

    PubMed 17723918

  • 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.

    PubMed 17116561

  • 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.

    PubMed 17578959

  • 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.

    PubMed 15973913

  • 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.

    PubMed 15004762

  • 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.

    PubMed 15535484

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

    PubMed 10655934

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

    PubMed 12243607

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine and Physiological serum in people with Hepatectomy and Pain, run by Centre Leon Berard at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption (time frame: In the 4 days following the hepatectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01194843, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in