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Completed

NCT Number: NCT00799175

Local Infiltration Analgesia Following Total Knee Arthroplasty

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Orebro, Örebro, Sweden

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About this study

Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for total knee arthroplasty
  • Aged 20-85 yrs
  • ASA physical status I-III and mobility indicating normal postoperative mobilization

Exclusion criteria

  • Known allergy or intolerance to one of the study drugs
  • Serious liver-, heart- or renal decease
  • Rheumatoid arthritis
  • Chronic pain or bleeding disorder

Treatment and study plan

ropivacaine, ketorolac and epinephrine

Drug

In Group A, 400 mg ropivicaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue. After 21 postoperative hours in Group A, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.

Saline

Drug

In Group P (placebo) no injections were given intraoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.

Primary outcomes

  1. Morphine consumption

    Time frame: 0-48 hours

Secondary outcomes

  1. hospital stay, pain intensity, side effects, knee function and patient satisfaction scores

    Time frame: 0-3 months

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty

Acronym: RAK-total

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 27, 2008
Registry last updated
Nov 27, 2008

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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