Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CDI-00301-2009
Study information
Scientific title
Epidural analgesia in video laparoscopic (VL) left hemicolectomy - optional and not mandatory choice in "Fast Track" treatment: a randomised controlled trial
Acronym
EAT IVA
Study hypothesis
Randomised trial conducted in order to quantify the concrete validity and limitations of intravenous patient-controlled analgesia therapy (IVA) versus epidural analgesic therapy (EAT) in "Fast Track" treatment of patients submitted to video laparoscopic left hemicolectomy.
Ethics approval
Ethics approval not required as the comparison in this trial was between two non-experimental procedures.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colorectal cancer
Intervention
After VL left hemicolectomy, patients would be provided analgesia in one of two ways: intravenous patient-controlled analgesia therapy (IVA) versus epidural analgesic therapy (EAT).
The following drugs were used:
IVA: Tramadol (400 mg/day), Ketoprofene (320 mg/day), Morphine (20 mg/day), Metoclopramide (20 mg/day), Ropivacaine cloridrate (12 - 28 mg/hour continuous infusion)
EAT: via epidural catheter (Naropine)
The average duration of treatment was 3.07 days for the IVA group and 4.05 days for the EAT group.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Pain control, measured with the Visual Analogue Scale (VAS) at day 0,1 and 2
Secondary outcome measures
1. Canalisation, measured daily
2. Drainage removal, measured daily
Overall trial start date
01/01/2007
Overall trial end date
30/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with neoplastic or recurrent flogistic pathology of the left colon
2. Patients with indication to VL surgery
3. Aged less than 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Patients over 80 years old
2. American Society of Anaesthesiologists (ASA) grade 4
Recruitment start date
01/01/2007
Recruitment end date
30/04/2009
Locations
Countries of recruitment
Italy
Trial participating centre
Via Alfieri 16
Milano
20154
Italy
Sponsor information
Organisation
Lecco Hospital Corporation (Azienda Ospedaliera Ospedale di Lecco) (Italy)
Sponsor details
Presidio di Merate Leopoldo Mandic
Merate
23900
Italy
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary