Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

Pain Clinical Trial

— DPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194843
• Other study ID #: DPO-Hepatectomy
• Secondary ID: ET2007-0732007-0
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: April 20, 2015
• Start date: March 2009
• Est. completion date: April 2015

Study information

• Verified date: January 2014
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatectomy
• Metastasis
• Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Centre Léon Bérard	LYON Cedex 08

Sponsors (3)

Lead Sponsor	Collaborator
Centre Leon Berard	AstraZeneca, Fondation Apicil

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Kwan AL. Epidural analgesia for patient undergoing hepatectomy. Anaesth Intensive Care. 2003 Apr;31(2):236-7. — View Citation

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

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. Epub 2006 Oct 25. Review. — View Citation

Mazoit JX, Butscher K, Samii K. Morphine in postoperative patients: pharmacokinetics and pharmacodynamics of metabolites. Anesth Analg. 2007 Jul;105(1):70-8. — View Citation

Murphy EJ. Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Anaesth Intensive Care. 2005 Jun;33(3):311-22. Review. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on morphine consumption		In the 4 days following the hepatectomy	No
Secondary	Efficacy of ropivacaine versus physiological serum administered by local infiltration and impact on daily morphine consumption		In the 4 days following the hepatectomy	No
Secondary	Evaluation of patients' perception of post-surgery pain		In the 4 days following the hepatectomy	No
Secondary	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	No
Secondary	Patients' post-surgery rehabilitation		Between surgery and follow-up visit, one month later	No
Secondary	Patients' satisfaction with the pain care		Four days after the hepatectomy	No