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| Sponsored by: |
University Hospital, Ghent |
|---|---|
| Information provided by: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00620477 |
Purpose
Patients who suffered from a rupture of the Anterior Cruciate Ligament with instability of the knee joint, will be treated with an operative ACL-reconstruction. One group of patients will stay one night in the hospital and go home the other day (Group I). The other group of patients will go home the same day of surgery (Group II). All patients will undergo the same arthroscopic reconstruction of the ACL. Anesthesia will be performed on each patient in a classic manner. At the end of the surgery each group of patients will be randomly divided in two subgroups: one group will get an injection in the knee joint with 30 ml of physiological fluid (Group Ia en IIa), the other group will get an injection in the knee joint with 30 ml of chirocaine 0.125%, a widely used pain-medicine (Group Ib and IIb). This will happen in a double blind, randomized way. The whole procedure takes about one hour.
After surgery patients are brought to the recovery room and are observed every 30 minutes for the duration of 4 hours. Before being brought to their rooms, patients will have to fill in a VAS: Visual Analogue Scale, to determine their pain. After being brought to their rooms, the patients will have the choice of going home the same day or staying in the hospital for one night, according to the amount of pain they are in. That moment it will be possible to switch groups. Patients who go home the same day of surgery will be contacted by phone the day after to fill in a question form. Patients who were admitted for one night will be seen before their leave to fill in the same question form.
| Condition | Intervention | Phase |
|---|---|---|
|
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint. |
Drug: injection in the knee joint with 30 ml of chirocaine 0.125% Drug: injection in the knee joint with 30 ml of physiological fluid |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Official Title: | Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
injection in the knee joint with 30 ml of chirocaine 0.125%
|
Drug: injection in the knee joint with 30 ml of chirocaine 0.125%
injection in the knee joint with 30 ml of chirocaine 0.125%
|
|
2: Placebo Comparator
injection in the knee joint with 30 ml of physiological fluid
|
Drug: injection in the knee joint with 30 ml of physiological fluid
injection in the knee joint with 30 ml of physiological fluid
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Luc Herregods, MD, PhD 0032(0)9 332 44 95 luc.herregods@ugent.be | |
| Contact: Fredrik Almqvist, MD, PhD 0032(0)9 332 22 24 Fredrik.almqvist@ugent.be | |
| Principal Investigator: Luc Herregods, MD, PhD | |
| Principal Investigator: Fredrik Almqvist, MD, PhD | |
| Principal Investigator: | Luc Herregods, MD, PhD | University Hospital, Ghent |
| Principal Investigator: | Fredrik Almqvist, MD, PhD | University Hospital, Ghent |
More Information
| Responsible Party: | University Hospital Ghent ( Luc Herregods, MD, PhD ) |
| Study ID Numbers: | 2008/068 |
| Study First Received: | February 8, 2008 |
| Last Updated: | April 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00620477 History of Changes |
| Health Authority: | Belgium: Institutional Review Board |
|
Levobupivacaine Central Nervous System Depressants Anesthetics |
Rupture Peripheral Nervous System Agents Anesthetics, Local |
|
Levobupivacaine Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |
