Evaluatie van Arthroscopisch Voorste Kruisband Herstel via Ziekenhuisopname of via Dagopname: een Gerandomiseerde Prospectieve Klinische Studie.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007668-15-BE

Enrollment

Registered

2007-12-17

Start date

2008-03-10

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint MedDRA version: 9.1 Level: LLT Classification code 10059062 Term: Anterior cruciate ligament tear

Interventions

Trade Name: Chirocaine Product Name: Chirocaine Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Levobupivacaine hydrochloride CAS Number: 27262482 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint Patients with a meniscal tear that can be sutured will also be included. Partial meniscectomies are accepted. All patients must be ASA I or ASA II classification. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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. Patients who are not fulfilling the ASA I or ASA II criteria or patients that take cardiovascular medicine will be excluded from the study. Pregnant women and nursing women will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: This study has the objective to determine whether it is possible to let patients go home the same day they underwent a repair of the anterior cruciate ligament, or whether they need to stay in the hospital for one night. This study also wants to determine if there is an effect of the injection of a pain-relieving drug after the operation on the duration of stay in the hospital.;Secondary Objective: ;Primary end point(s): Visual Analogue Scale within 4 hours Question Form, Visual Analogue Scale one day after surgery	—

Measure

Time frame

Main Objective: This study has the objective to determine whether it is possible to let patients go home the same day they underwent a repair of the anterior cruciate ligament, or whether they need to stay in the hospital for one night. This study also wants to determine if there is an effect of the injection of a pain-relieving drug after the operation on the duration of stay in the hospital.;Secondary Objective: ;Primary end point(s): Visual Analogue Scale within 4 hours Question Form, Visual Analogue Scale one day after surgery

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026