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

NCT01890408 | Terminated Phase 2

• 1 other identifier: P111101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparotomy; Hepatic Resection

Keywords

Laparotomy; Hepatic resection; continuous wound catheter analgesia; morphine; post operative recovery

Outcome Measures

Primary Outcomes (1)

• the opioid-related symptom distress scale (SDS)

  48 h postoperatively

Secondary Outcomes (3)

• Diaphragmatic function

  48 h, 5 days postoperatively and discharge

• total morphine consumption

  48 h, 5 days postoperatively and discharge

• Recovery after surgery

  48 h, 5 days postoperatively and discharge

Study Arms (2)

ropivacaine

EXPERIMENTAL

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

Drug: wound infusion ropivacaine

placebo

PLACEBO COMPARATOR

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

Interventions

wound infusion ropivacaine DRUG

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.

ropivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Département anesthésie-réanimation

Paris, 75012, France

Location

Study Officials

• Thibault Camus, Dr

  Assistance Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: July 1, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

FR (1)