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

Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty

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).

Study Overview

• Status: Completed
• Conditions: Knee Replacement Arthroplasty
• Intervention / Treatment: Drug: Saline; Drug: Ropivacaine 7,5 mg/ml

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Saline; Other Names: Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml; Sodium 9g/l; Electrolyte content: Na+ 154 mmol/l; Cl- 154 mmol/l; Infusion mixture; Drug: Ropivacaine 7,5 mg/ml; Other Names: Product name: Ropivacain "Fresenius Kabi"; Ropivacainhydrochloridmonohydrat; Importet to Denmark by Fresenius Kabi AB; Injection mixture
Placebo Comparator: 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	Drug: Saline; Other Names: Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml; Sodium 9g/l; Electrolyte content: Na+ 154 mmol/l; Cl- 154 mmol/l; Infusion mixture; Drug: Ropivacaine 7,5 mg/ml; Other Names: Product name: Ropivacain "Fresenius Kabi"; Ropivacainhydrochloridmonohydrat; Importet to Denmark by Fresenius Kabi AB; Injection mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between groups in muscle strength of the quadriceps femoris muscle.	Same as primary outcome	120 minutes after initial ACB (T120)
VAS pain scores at rest	Pain at rest (VAS 0-100 mm) one hour after the first and second ACB. Results will be compared between the two groups. VAS pain scores at rest will be inquired before any other outcome measurements.	60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
VAS pain score during TUG test.	Highest VAS (0-100 mm) pain score during TUG test will be inquired for each TUG test. Results will be compared between the two groups.	60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Timed Up and Go(TUG) test	Time (seconds) to complete a TUG test measured one hour after the first and second ACB. Results will be compared between the two groups.	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	Specification of pain (VAS 0-100 mm) during 45 degrees active flexion of the knee one hour after first and second ACB. Results will be compared between the two groups.	60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block	According to their specified VAS (0-100 mm) pain score during active flexion of the knee prior to the first block, patients will be divided into two groups. Group 1 VAS 0-59 mm and group 2 with VAS 60-100 mm. Results within the two groups will be compared: e.g is there a difference in MVIC in the subgroup of patients scoring VAS 0-59 during active knee flexion at baseline? and is this difference larger in the subgroup of patients scoring VAS 60-100?	60 minutes after first ACB (T60)

Collaborators and Investigators

• Sponsor: Ulrik Grevstad
• Investigators: Principal Investigator: Ulrik Grevstad, MD, Gentofte Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Postoperative Pain; Mobilization; Knee surgery; Saphenous nerve; Perineural block; Adductor Canal Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2014-002245-21