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Completed

NCT Number: NCT00269529

Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study

The study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in the groin.

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Key information

Conditions

Arthroplasty, Replacement, Knee Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Hospital, Tage Hansens Gade

Aarhus, DK-8000, Denmark

About this study

Postoperative pain after total knee arthroplasty is moderate to severe and can be difficult to treat. The current use of femoral nerve block by ropivacain pump for 48 hours provides considerable analgesia, but patients often experience slight motor block, inhibiting rehabilitation, and pain in the posterior part of the knee, innervated by the sciatic nerve. This study compares femoral nerve block to a new technique, where ropivacaine, ketorolac and adrenalin is used to infiltrate the tissue in and around the knee joint during surgery, and is injected by an intraarticular catheter at 10 pm on the day of surgery and again at 10 am the day after. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first four postoperative days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients planned for primary total knee arthroplasty due to primary arthrosis

Exclusion criteria

  • Patients unable to provide informed consent
  • patients with contraindications for spinal anesthesia
  • patients with known hypersensitivity towards the used drugs
  • patients with severe chronic neurogenic pain or sensitivity disorders in the leg to be operated
  • patients who have undergone major bone surgery in the knee to be operated

Treatment and study plan

Femoral Nerve Block

Procedure

knee infiltration and injection via catheter

Procedure

Primary outcomes

  1. pain, by numeric rating scale

  2. pain, by consumption of analgesics

  3. side effects

  4. return of function

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • The Danish Medical Research Council

Registry information

Official study title

Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Femoral Block and Extensive Intraoperative Infiltration With Local Anesthetic Supplemented With Intraarticular Bolus the Following Day.

Important dates

Study start
2005
Study completion
2006
First posted
Dec 23, 2005
Registry last updated
Oct 13, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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