ROPIHEP: Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ropivacaine patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period |
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.
|
| Placebo Comparator: placebo patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period |
Outcome Measures
Primary Outcome Measures
- the opioid-related symptom distress scale (SDS) [48 h postoperatively]
Secondary Outcome Measures
- 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
Eligibility Criteria
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:
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Age < 18 years
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Severe hepatic
-
Renal impairment
-
Pregnancy or lactation
-
Allergy to one of the specific drugs under study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Département anesthésie-réanimation | Paris | France | 75012 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Thibault Camus, Dr, Assistance Publique
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P111101