Local Infiltration Analgesia Following Total Knee Arthroplasty (RAK-total)

This study has been completed.
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00799175
First received: November 26, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Postoperative Pain
Drug: ropivacaine, ketorolac and epinephrine
Drug: saline

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

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hospital stay, pain intensity, side effects, knee function and patient satisfaction scores [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Group A(Active)
Group A (Active) receives a multimodal injection intra- and postoperatively
Drug: ropivacaine, ketorolac and epinephrine
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.
Placebo Comparator: 2 Group P (Placebo)
Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
Drug: saline
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799175

Locations
Sweden
University Hospital Orebro
Orebro, Sweden, 701 85
University Hospital Orebro
Orebro, Sweden, 70185
Sponsors and Collaborators
University Hospital Orebro
Investigators
Principal Investigator: Kjell Axelsson, Prof University Hospital Orebro, Sweden
  More Information

No publications provided

Responsible Party: Kjell Axelsson, Prof, University Hospital Orebro, Orebro, Sweden
ClinicalTrials.gov Identifier: NCT00799175     History of Changes
Other Study ID Numbers: RAK-total
Study First Received: November 26, 2008
Last Updated: November 26, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital Orebro:
Postoperative pain
Local infiltration analgesia
Knee arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Epinephrine
Racepinephrine
Epinephryl borate
Ketorolac
Ketorolac Tromethamine
Ropivacaine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on August 19, 2014