| - candidate number | 2353 |
| - NTR Number | NTR848 |
| - ISRCTN | Incomplete info for ISRCTN |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 5-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Epidural anesthesia compaired to general anesthesia for lumbal spinal surgery (Voordeurstudie study). |
| - Scientific Title | Epidural anesthesia compaired to general anesthesia for lumbal spinal surgery (Voordeurstudie study). |
| - ACRONYM | De Voordeurstudie |
| - hypothesis | Epidural anesthesia is superiour to general anesthesia considering pain control, blood loss, urine retention, recovery duration and general well being for the patient. |
| - Healt Condition(s) or Problem(s) studied | Lumbal spinal surgery |
| - Inclusion criteria | Patients from 18 years old who are ASA<3. |
| - Exclusion criteria | ASA 3-5 patients and those who received lower back surgery twice or more. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jan-2007 |
| - planned closingdate | 31-dec-2007 |
| - Target number of participants | 200 |
| - Interventions | 1. Study group: epidural anesthesia; 2. Control group: general anesthesia. |
| - Primary outcome | Pain perception post OK using the visual analog scale (VAS). |
| - Secondary outcome | 1. Blood loss; 2. Blood pressure variations; 3. Feed back from the patients recovery time; 4. Postoperative nausia and vomiting; 5. Urine retention; 6. Patient satisfaction. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Dr. M.B. Godfried |
| - CONTACT for SCIENTIFIC QUERIES | Dr. M.B. Godfried |
| - Sponsor/Initiator | |
| - Funding (Source(s) of Monetary or Material Support) | |
| - Publications | N/A |
| - Brief summary | Lumbar spinal cord surgery can be performed safely under general anesthesia (GA) or epidural anesthesia (EA). GA is mostly preferred because of greater patient and physician acceptance and the ability to perform operations of longer duration in the prone position with a safe airway. It is demonstrated that regional anesthesia reduces blood loss (1) . During EA the awake patient can self-position to avoid nerve injury of the brachial plexus and pressure necrosis especially to the face. In addition, the perioperative feed-back of the patient allows precise localisation of the involved nerve root to the surgeon and guarding against injuries. Finally, this technique provides excellent long lasting postoperative analgesia . Proposed disadvantages of EA for this surgery are the inability to immediately assess the neurological function, and affected bladder function. The Sint Lucas Andreas Hospital has performed EA for lumbar spine surgery successfully since the early eighteis. Although the broad experience this has never been evaluated for perioperative blood loss, time of discharge from the recovery unit and the common postoperative problems such as pain, analgesic need, nausea, and vomiting. |
| - Main changes (audit trail) | |
| - RECORD | 5-dec-2006 - 18-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl