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Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrik Grevstad, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01549704
First received: March 1, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during knee flexion the 1. or 2. day after surgery.


Condition Intervention Phase
Pain After Total Knee Arthroplasty
 Drug: Ropivacaine
Drug: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Difference in VAS between ACB and placebo during active 45 degrees knee flexion [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in mean VAS between the groups during active knee flexion [ Time Frame: 15, 30, 60, 75 and 90 minutes ] [ Designated as safety issue: No ]
  • Difference in mean VAS between the groups at rest [ Time Frame: 15, 30, 60, 75 and 90 minutes ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm RP
first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
 Drug: Ropivacaine

Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).

Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.

Other Name: Naropin
Drug: Saline
please see intervention description for ropivacaine
Other Name: NaCl, placebo
Arm PR
first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml
 Drug: Ropivacaine

Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).

Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.

Other Name: Naropin
Drug: Saline
please see intervention description for ropivacaine
Other Name: NaCl, placebo

Detailed Description:

The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS > 60 during active 45 degrees knee flexion will be asked to participate.

Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • TKA within 48 hours and VAS>60 during active 45 degrees knee flexion despite conventional pain medication.
  • Informed consent
  • ASA 1-3
  • BMI 18-40

Exclusion Criteria:

  • Unable to communicate in Danish
  • Allergic reactions toward drugs used in the
  • Abuse of alcohol/drugs
  • Unable to cooperate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549704

Locations
Denmark
Gentofte Hospital
Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Ulrik Grevstad, MD Gentofte Hospital
  More Information

No publications provided

Responsible Party: Ulrik Grevstad, Consultant, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01549704     History of Changes
Other Study ID Numbers: SM1-UG-11
Study First Received: March 1, 2012
Last Updated: January 7, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: National Board of Health

Keywords provided by University Hospital, Gentofte, Copenhagen:
Total knee arthroplasty
Adductor canal blockade (ACB)
High pain responders
US-guided nerve block

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013