Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty

NCT ID: NCT02242591

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-11-30

Brief Summary

The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (TKA).

Detailed Description

Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.

At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).

At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).

Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.

Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.

Conditions

Knee Replacement Arthroplasty

Study Design

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

Study Groups

ACB_active/placebo

Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0).

The measurements for baseline and outcome will be made in following order:

VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test

Group Type: ACTIVE_COMPARATOR

Ropivacaine 7,5 mg/ml

Intervention Type: DRUG

Saline

Intervention Type: DRUG

ACB_placebo/active

Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0).

The measurements for baseline and outcome will be made in following order:

VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test

Group Type: PLACEBO_COMPARATOR

Ropivacaine 7,5 mg/ml

Intervention Type: DRUG

Saline

Intervention Type: DRUG

Interventions

Ropivacaine 7,5 mg/ml

Intervention Type: DRUG

Saline

Intervention Type: DRUG

Other Intervention Names

Product name: Ropivacain "Fresenius Kabi"; Ropivacainhydrochloridmonohydrat; Importet to Denmark by Fresenius Kabi AB; Injection mixture; Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml; Sodium 9g/l; Electrolyte content: Na+ 154 mmol/l; Cl- 154 mmol/l; Infusion mixture

Eligibility Criteria

Inclusion Criteria

• Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
• Written informed consent.
• ASA 1-3

Exclusion Criteria

• Non-cooperative patients
• Patients who have already had a peripheral or central block post surgery.
• Patients who are not able to perform a TUG test pre surgery.
• Patients who do not understand or speak Danish.
• Patient who are allergic to the drugs used in this research.
• Patients with alcohol- or drug abuse - determined by investigator.
• Patients with peripheral sensory neuropathy in their lower extremities.
• Pregnant patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulrik Grevstad

OTHER

Sponsor Role: lead

Responsible Party

Ulrik Grevstad

Consultant, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulrik Grevstad, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte Hospital

Locations

Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

2014-002245-21

Identifier Type: -

Identifier Source: org_study_id