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

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 2

Conditions: Laparotomy; Hepatic Resection

Treatments: Drug: wound infusion ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01890408

P111101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

ropivacaine

Experimental group

Description:

patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period

Treatment:

Drug: wound infusion ropivacaine

placebo

Placebo Comparator group

Description:

patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period