Local Infiltration Versus Block Against Pains After High Tibial Osteotomy

NCT ID: NCT01537146

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so that both healing and rehabilitation are served optimally.

Detailed Description

Axis corrective surgery of the knee is an attractive alternative to the knee prosthesis in young active patients with unilateral osteoarthritis of the knee. The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee pain can be treated more appropriately, so that both healing and rehabilitation are served optimally.

Proximal open-wedge tibia osteotomy is an accepted treatment option for younger patients with unilateral osteoarthritis of knee. 70 such operations are performed in the investigators Orthopaedic Divisions each year. The surgery involves cutting through the upper end of the tibia and opens the bone using specialized instruments. The tibia is lengthened on the medial side with the purpose of correcting the mechanical axis of the knee joint. The surgery is associated with many pains in the early postoperative phase. Until now, pain treatment has been controlled with either epidural block, or regional block via femoral catheter. Both treatments may involve risks such as loss of strength and sensibility disturbance, which often prolongs the early recovery and mobilization. Moreover, pain treatment administered via femoral catheter is often not sufficient as a part of the area behind the knee joint is not covered.

With the advent of new pain therapies, particularly intra operative administration of local anaesthetics directly in the operating field and catheter administration for postoperative pain management, there is hope that those disadvantages are eliminated. By ensuring an effective pain treatment and the possibility of early mobilization only hours after completion of surgery, this will allow for better patient care in terms of reduced pain, shorter hospitalization and quicker rehabilitation.

New results show that the healing of bone opening is not compromised by rapid mobilization. The migration of bone parts around the opening is measured by roentgen stereometric analysis (RSA), with a precision of approximately 0.2 mm. This verifies stable healing of the bone opening.

Conditions

Osteoarthritis; Malalignment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Femoral Block

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Bolus infusion via catheter/6H for 24H

Local Infiltration Anagesia

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H

Interventions

Ropivacaine

Bolus infusion via catheter/6H for 24H

Intervention Type: DRUG

Ropivacaine

Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H

Intervention Type: DRUG

Other Intervention Names

No other names; no other names

Eligibility Criteria

Inclusion Criteria

• Planned primary open-wedge high tibia osteotomy
• Patients (male/female) ≥ 18 år
• Patients giving written informed consent and authority.
• Patients receiving epidural anaesthesia

Exclusion Criteria

• Patients with intolerance to trial medications
• Rejection of or contraindicated epidural anaesthesia
• Patients with rheumatoid arthritis.
• Patients with Body Mass Index (BMI) ≥ 35
• Patients that do not read or write Danish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders C Laursen, MD

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Division, Denmark

Mogens B Laursen, MD, PhD

Role: STUDY_CHAIR

Northern Orthopaedic Division, Denmark

Locations

Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Countries

Denmark

Other Identifiers

ON-04-019-ACL

Identifier Type: -

Identifier Source: org_study_id