Epidural Analgesic Therapy (EAT) versus IntraVenous patient-controlled Analgesia (IVA)
| ISRCTN | ISRCTN79187946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79187946 |
| Protocol serial number | CDI-00301-2009 |
| Sponsor | Lecco Hospital Corporation (Azienda Ospedaliera Ospedale di Lecco) (Italy) |
| Funder | Investigator initiated and funded (Italy) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Pain control, measured with the Visual Analogue Scale (VAS) at day 0,1 and 2 |
| Key secondary outcome measure(s) |
1. Canalisation, measured daily |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
