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

Phase 2

Terminated

• Conditions: Hepatic Resection; Laparotomy
• Interventions: Drug: wound infusion ropivacaine

• Registration Number: NCT01890408
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-01
• Study Start: 2013-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

• Age < 18 years
• Severe hepatic
• Renal impairment
• Pregnancy or lactation
• Allergy to one of the specific drugs under study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine	wound infusion ropivacaine	patients scheduled to undergo open liver resection Age \> 18 years Free from pain in preoperative period

Primary Outcome Measures

Name	Time	Method
the opioid-related symptom distress scale (SDS)	48 h postoperatively

Secondary Outcome Measures

Name	Time	Method
Diaphragmatic function	48 h, 5 days postoperatively and discharge	Sniff-test and Peak-flow
total morphine consumption	48 h, 5 days postoperatively and discharge
Recovery after surgery	48 h, 5 days postoperatively and discharge	It is defined as the time to first flatus and recovery of bowel activity after surgery

Trial Locations

Locations (1)

Département anesthésie-réanimation; 🇫🇷 Paris, France