Clinical trial NCT01890408: Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity.
Official title: Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Laparotomy
Hepatic Resection
Keywords: Laparotomy
Hepatic resection
continuous wound catheter analgesia
morphine
post operative recovery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the opioid-related symptom distress scale (SDS)
timeFrame: 48 h postoperatively
Secondary outcomes:
measure: Diaphragmatic function
timeFrame: 48 h, 5 days postoperatively and discharge
measure: total morphine consumption
timeFrame: 48 h, 5 days postoperatively and discharge
measure: Recovery after surgery
timeFrame: 48 h, 5 days postoperatively and discharge
Other outcomes:
Locations:
city: Paris
country: France
facility: Département anesthésie-réanimation
Study officials:
affiliation: Assistance Publique
name: Thibault Camus, Dr
role: PRINCIPAL_INVESTIGATOR
References: