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

Knee Replacement Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242591
• Other study ID #: 2014-002245-21
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2014
• Last updated: November 26, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Replacement Arthroplasty

Intervention

Drug:
• Ropivacaine 7,5 mg/ml

• Saline

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Ulrik Grevstad

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Difference between groups in muscle strength of the quadriceps femoris muscle.	Same as primary outcome	120 minutes after initial ACB (T120)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No