The effect of adductor canal block vs. placebo on muscle strength, mobilisation and pain on the first day after knee replacement surgery

Effect of adductor canal block vs. placebo on muscle strength, mobilisation and pain on the first post-operative day after total knee athroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002245-21-DK

Enrollment

Registered

2014-06-03

Start date

2014-07-02

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of post-operative pain after total knee athroplasty MedDRA version: 17.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Ropivacaine Pharmaceutical Form: Injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 18-85 years. ASA 1-3. Total knee replacement during the last 48 hours. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: Allergy to to study drug. Unable to preform TUG test preoperative. Patients who have recieved a peripheral or central nerve block post operatively. Peripheral neuropathy. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effect of adductor canal block vs. placebo on quadriceps mucle strength assesed by maximum voluntary isometric contraction (MVIC) as procentage of the postoperative preblock baseline, one hour post block. ;Primary end point(s): Effect of adductor canal block vs. placebo on quadriceps mucle strength assesed by maximum voluntary isometric contraction (MVIC) as procentage of the postoperative preblock baseline.;Timepoint(s) of evaluation of this end point: One hour post block. ;Secondary Objective: Difference in time (seconds) to complete the timed-up-and-go (TUG) test one and two hours post block, between groups. Difference between the groups, in pain at rest (VAS 0-100 mm) at one and two hours post block. Difference between the groups, in pain during 45 degreees flexion of the knee (VAS 0-100 mm) at one and two hours post block. Difference between the groups, in worst pain experienced during the TUG test (VAS 0-100 mm) at one and two hours post block. Finally, we plan to perfrom a subgroup analysis of muscle strength and time to perfrom the TUG test, by dividing the patients in two groups according to initial pain ( pre block) scores during 45 degrees active knee flexion. Group 1: 0-59 mm VAS score, and group 2: 60-100 mm VAS.	—

Measure

Time frame

Main Objective: Evaluate the effect of adductor canal block vs. placebo on quadriceps mucle strength assesed by maximum voluntary isometric contraction (MVIC) as procentage of the postoperative preblock baseline, one hour post block. ;Primary end point(s): Effect of adductor canal block vs. placebo on quadriceps mucle strength assesed by maximum voluntary isometric contraction (MVIC) as procentage of the postoperative preblock baseline.;Timepoint(s) of evaluation of this end point: One hour post block. ;Secondary Objective: Difference in time (seconds) to complete the timed-up-and-go (TUG) test one and two hours post block, between groups. Difference between the groups, in pain at rest (VAS 0-100 mm) at one and two hours post block. Difference between the groups, in pain during 45 degreees flexion of the knee (VAS 0-100 mm) at one and two hours post block. Difference between the groups, in worst pain experienced during the TUG test (VAS 0-100 mm) at one and two hours post block. Finally, we plan to perfrom a subgroup analysis of muscle strength and time to perfrom the TUG test, by dividing the patients in two groups according to initial pain ( pre block) scores during 45 degrees active knee flexion. Group 1: 0-59 mm VAS score, and group 2: 60-100 mm VAS.

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Secondary

Measure	Time frame
Secondary end point(s): Difference in time (seconds) to complete the timed-up-and-go (TUG) test between groups. Difference between the groups, in pain at rest (VAS 0-100 mm). Difference between the groups, in pain during 45 degreees flexion of the knee (VAS 0-100 mm). Difference between the groups, in worst pain experienced during the TUG test (VAS 0-100 mm). Finally, we plan to perfrom a subgroup analysis of muscle strength and time to perfrom the TUG test, by dividing the patients in two groups according to initial pain ( pre block) scores during 45 degrees active knee flexion. Group 1: 0-59 mm VAS score, and group 2: 60-100 mm VAS. ;Timepoint(s) of evaluation of this end point: One and two hours post block.	—

Measure

Time frame

Secondary end point(s): Difference in time (seconds) to complete the timed-up-and-go (TUG) test between groups. Difference between the groups, in pain at rest (VAS 0-100 mm). Difference between the groups, in pain during 45 degreees flexion of the knee (VAS 0-100 mm). Difference between the groups, in worst pain experienced during the TUG test (VAS 0-100 mm). Finally, we plan to perfrom a subgroup analysis of muscle strength and time to perfrom the TUG test, by dividing the patients in two groups according to initial pain ( pre block) scores during 45 degrees active knee flexion. Group 1: 0-59 mm VAS score, and group 2: 60-100 mm VAS. ;Timepoint(s) of evaluation of this end point: One and two hours post block.

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Countries

Denmark

Contacts

Public ContactGentofte Hospital, Dept. of anaest.

Ulrik Grevstad

ulrik.grevstad@hotmail.com004539773892

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026