Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial
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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 20 ml of physiological fluid (Group Ia en IIa), the other group will get an injection in the knee joint with 20 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 20 ml of chirocaine 0.125% Drug: injection in the knee joint with 20 ml of physiological fluid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- Visual Analogue Scale [ Time Frame: within 4 hours after surgery ] [ Designated as safety issue: No ]
- Question Form, Visual Analogue Scale [ Time Frame: one day after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
injection in the knee joint with 20 ml of chirocaine 0.125%
|
Drug: injection in the knee joint with 20 ml of chirocaine 0.125%
injection in the knee joint with 20 ml of chirocaine 0.125%
|
|
Placebo Comparator: 2
injection in the knee joint with 20 ml of physiological fluid
|
Drug: injection in the knee joint with 20 ml of physiological fluid
injection in the knee joint with 20 ml of physiological fluid
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint will be included in the study.
- Patients with a meniscal tear that can be sutured will also be included. Partial meniscectomies are accepted.
Exclusion Criteria:
- Patients with chronic laxity (longer than 9 months), associated collateral laxity (grade III), subtotal or total meniscectomy, infection or inflammatory disease of the knee joint or large cartilage lesion will not be included in the study.
Contacts and Locations| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Luc Herregods, MD, PhD +32 9 332 44 95 luc.herregods@ugent.be | |
| Contact: Fredrik Almqvist, MD, PhD +32 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
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00620477 History of Changes |
| Other Study ID Numbers: | 2008/068 |
| Study First Received: | February 8, 2008 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Institutional Review Board Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Rupture Wounds and Injuries Levobupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013