Epidural Analgesic Therapy (EAT) versus IntraVenous patient-controlled Analgesia (IVA)
| ISRCTN | ISRCTN79187946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79187946 |
| Secondary identifying numbers | CDI-00301-2009 |
- Submission date
- 10/06/2009
- Registration date
- 04/08/2009
- Last edited
- 04/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pierpaolo Caputo
Scientific
Scientific
Via Alfieri 16
Milano
20154
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Epidural analgesia in video laparoscopic (VL) left hemicolectomy - optional and not mandatory choice in "Fast Track" treatment: a randomised controlled trial |
| Study acronym | EAT IVA |
| Study objectives | 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(s) | Ethics approval not required as the comparison in this trial was between two non-experimental procedures. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2007 |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key exclusion criteria | 1. Patients over 80 years old 2. American Society of Anaesthesiologists (ASA) grade 4 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Alfieri 16
Milano
20154
Italy
20154
Italy
Sponsor information
Lecco Hospital Corporation (Azienda Ospedaliera Ospedale di Lecco) (Italy)
Hospital/treatment centre
Hospital/treatment centre
Presidio di Merate Leopoldo Mandic
Merate
23900
Italy
| Website | http://www.ospedale.lecco.it/ |
|---|
Funders
Funder type
Other
Investigator initiated and funded (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
