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

NCT02242591 | Completed Phase 4 DMC

• 1 other identifier: 2014-002245-21
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Replacement Arthroplasty

Keywords

Knee surgery; Saphenous nerve; Perineural block; Adductor Canal Block; Postoperative Pain; Mobilization

Outcome Measures

Primary Outcomes (1)

• Difference between groups in muscle strength of the quadriceps femoris muscle.

  Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3 consecutive measurements will be made and the average used. Results for each group will be presented as percentage of baseline values. The primary outcome is the difference in MVIC between the groups.

  60 minutes after first ACB (T60)

Secondary Outcomes (6)

• Difference between groups in muscle strength of the quadriceps femoris muscle.

  120 minutes after initial ACB (T120)

• VAS pain scores at rest

  60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)

• VAS pain score during TUG test.

  60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120

• Timed Up and Go(TUG) test

  60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120

• VAS pain scores during 45 degrees active flexion of the knee

  60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120

Study Arms (2)

ACB_active/placebo

ACTIVE COMPARATOR

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

Drug: Ropivacaine 7,5 mg/ml; Drug: Saline

ACB_placebo/active

PLACEBO COMPARATOR

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

Drug: Ropivacaine 7,5 mg/ml; Drug: Saline

Interventions

Ropivacaine 7,5 mg/ml DRUG

Also known as: Product name: Ropivacain "Fresenius Kabi", Ropivacainhydrochloridmonohydrat, Importet to Denmark by Fresenius Kabi AB, Injection mixture

ACB_active/placebo; ACB_placebo/active

Saline DRUG

Also known as: Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml, Sodium 9g/l, Electrolyte content: Na+ 154 mmol/l, Cl- 154 mmol/l, Infusion mixture

ACB_active/placebo; ACB_placebo/active

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• ASA 1-3

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulrik Grevstad: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride; Sodium; Chlorides

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Metals, Alkali; Elements; Metals, Light; Metals; Anions; Ions; Electrolytes

Study Officials

• Ulrik Grevstad, MD

  Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, MD

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 17, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

DK (1)