Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity.

Laparotomy Clinical Trial

— ROPIHEP  

Official title:

Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01890408
• Other study ID #: P111101
• Status: Terminated
• Phase: Phase 2
• First received: June 14, 2013
• Last updated: June 25, 2014
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver resection. But, opioids tend to be ineffective for pain that is associated with movement and have significant short-term side effects including nausea, vomiting, sedation, pruritus, constipation, urinary, retention, and respiratory depression, which are factors that often hinder a patient's recovery. Prospective randomized trials has found continuous wound catheter analgesia as an accepted alternative to IV morphine PCA.

The researchers will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce morbidity and provide a better recovery.

Description:

This study is a prospective, double blind, randomized study. Subjects will be randomized using a computer-generated table of random numbers into 2 groups. The patients scheduled to undergo open liver resection will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B). The patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (10-ml bolus followed by an infusion of 10 ml/h during 48 h) or the same protocol with 0.9% NaCl (control group), thanks to a elastomeric pump (500ml), set to deliver a 10-ml/h connected with the catheter. In addition, all patients will receive patient-controlled intravenous morphine analgesia. The primary endpoint : the opioid-related symptom distress scale (SDS) will be performed at 48 hours after surgery. Secondary endpoints will be pain intensity on a visual analog scale at rest, and on coughing, morphine consumption, respiratory dysfunction, transit recovery and side effects at 48 hours, 5 days after surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA I-III

• Scheduled for open hepatic resection

• Patients must be able to understand the IV morphine PCA

• Written informed consent

• Free from pain in preoperative period

Exclusion Criteria:

• Age < 18 years

• Severe hepatic

• Renal impairment

• Pregnancy or lactation

• Allergy to one of the specific drugs under study

Study Design

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

Related Conditions & MeSH terms

• Hepatic Resection
• Laparotomy

Intervention

Drug:
• wound infusion ropivacaine
Laparotomy Hepatic surgery : Bolu of 10 ml de ropivacaine 0,2% + infusion with elastomeric pump with ropivacaine 0,2% at a 10ml/h during 48 hours.

Locations

Country	Name	City	State
France	Département anesthésie-réanimation	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the opioid-related symptom distress scale (SDS)		48 h postoperatively	No
Secondary	Diaphragmatic function	Sniff-test and Peak-flow	48 h, 5 days postoperatively and discharge	No
Secondary	total morphine consumption		48 h, 5 days postoperatively and discharge	No
Secondary	Recovery after surgery	It is defined as the time to first flatus and recovery of bowel activity after surgery	48 h, 5 days postoperatively and discharge	No