Outcomes After Total Knee Joint Arthroplasty : A Comparative Study Using 3 Different Analgesic Techniques

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Sugantha Ganapathy, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01503528
First received: January 2, 2012
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

This study is designed to determine if three different methods for providing postoperative analgesia following total knee joint arthroplasty affect outcomes. These outcomes include pain and function for a period of up to 3 months, and specific non-pain outcomes, including cardiac, respiratory, central nervous system, thromboembolism, infection, nausea and vomiting and urinary retention.

Economic outcomes will also be examined, including length of hospital stay, direct health care costs and patient satisfaction.


Condition Intervention Phase
Knee Joint Arthritis
Knee Joint Arthroplasty
Procedure: Spinal anesthesia with periarticular infiltration
Procedure: Femoral and sciatic nerve blocks
Procedure: Periarticular infusions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes After Total Knee Joint Arthroplasty : A Comparative Study Using 3 Different Analgesic Techniques

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Primary outcome - incidence of global adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    A composite rate of perioperative adverse events, including MI, DVT/PE, delirium, pneumonia, paralytic ileus, GI bleed, new onset renal dysfunction, wound infection will be used.


Secondary Outcome Measures:
  • Perioperative pain [ Time Frame: Every 6 hours up to a total of 72 hours. ] [ Designated as safety issue: No ]
    Postoperative pain levels on a visual analogue scale will be recorded while the patient is an inpatient up to a maximum of 72 hours.

  • Postoperative mobility [ Time Frame: Measured at day 3, 1 month and 3 months. ] [ Designated as safety issue: No ]
    Postoperative mobility will be assessed by a blinded physiotherapist using the 'Timed up-and-go' or 'TUG' test. This test assess how long it takes for a patient to rise from a chair, walk a fixed distance then return and sit again.

  • Skin hypersensitivity [ Time Frame: 3 and 6 months post operation. ] [ Designated as safety issue: No ]
    Skin hypersensitivity will be assessed using Von Frey hair technique at 3 and 6 months postop, and the area in square millimetres recorded.

  • Patient reported pain, stiffness and functional disability. [ Time Frame: Assessed preoperatively, and at 1 and 3 months postoperative. ] [ Designated as safety issue: No ]
    These variables will be assesed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC score).


Estimated Enrollment: 750
Study Start Date: July 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spinal anesthesia and local infiltration
Group S will receive spinal anesthesia and periarticular infiltration. Postoperatively they will receive patient controlled analgesia with hydromorphone. On termination of PCA, they will receive a combination of oral oxycodone and oxycontin.
Procedure: Spinal anesthesia with periarticular infiltration

Spinal anesthesia with 15 mg of hyperbaric bupivacaine and periarticular infiltration will be given. Postoperatively patients will receive patient controlled analgesia with hydromorphone at a dose of 0.1- 0.3mg with a lock out of 6 minutes for 24 hours. On termination of PCA, they will receive a combination of oxycodone and oxycontin.

Patients will also receive peri-articular infiltration with a mixture of ropivacaine (300mg), ketorolac 30 mg, morphine 10 mg and epinephrine 2.5mcg/mL in 110mL.

Active Comparator: Femoral and sciatic nerve blocks
This group will have continuous femoral and sciatic nerve blocks initiated in the preoperative period in the block room as per our standard practice and continued for 48 hours. This group will receive spinal anesthesia. This group will not receive peri-articular infiltration.
Procedure: Femoral and sciatic nerve blocks
Continuous femoral (20mL of 0.2% ropivacaine as the initial bolus) and sciatic (10 mL of 0.1% ropivacaine as initial bolus) nerve blocks will be initiated in the preoperatively and continued for 48 hours. This group will receive spinal anesthetic with 15 mg of hyperbaric bupivacaine. This group will not receive peri-articular infiltration. The femoral block will be patient controlled regional analgesia with 0.13%-0.2% ropivacaine, basal rate 5mL/h and patient controlled bolus of 5 mL every hour as needed. The sciatic infusion will be 4mL/hour as continuous infusion. Nurse administered boluses of 10mL of the corresponding solution will be allowed for breakthrough pain. The blocks will be held at 6AM on Postoperative day 2. In the event of inadequate analgesia, and following block discontinuation the patients will receive oxycodone and oxycontin.
Experimental: Periarticular infusion group
Group W will have 3 peri-articular catheters inserted at the end of surgery following periarticular infiltration and wound infusions will be continued for 48 hrs using elastomeric infusion devices. They will receive spinal anesthesia with 15 mg of hyperbaric bupivacaine. They will receive oxycodone and oxycontin as needed.
Procedure: Periarticular infusions

3 peri-articular catheters will inserted at the end of surgery following periarticular infiltration and wound infusions will be continued for 48 hrs using elastomeric infusion devices. They will receive spinal anesthetic with 15 mg of hyperbaric bupivacaine. They will receive oxycodone and oxycontin.

This group will also receive peri-articular infiltration with a mixture of ropivacaine (300mg), ketorolac 30 mg, morphine 10 mg and epinephrine 2.5mcg/mL in 110mL.


Detailed Description:

Our objective is to compare the three analgesic regimes for total knee joint arthroplasty currently practiced at our institution with regard to their impact on patient outcomes in the immediate postoperative period and for up to 6 months. The outcome measures that we will be prospectively looking at are:

A. Pain and functional outcomes: Twice a day pain scores following activity during the in hospital stay, number of days that patient requires oral narcotics, presence of complex regional pain syndrome, presence and extent of wound hyperalgesia at 3 months, WOMAC scores preoperatively and at 6weeks and 3 months. 'Timed up and go' test will be performed on day 3 or at discharge and at 2 weeks and 3 months. Incidence of falls while in hospital and following discharge.

B. Specific non pain outcomes Cardiac: Myocardial infarction, myocardial ischemia, Congestive failure, new onset arrhythmia, death Respiratory: Hypoxia requiring supplemental oxygen beyond 24 hours, pneumonia, pneumonia requiring prolonged hospital stay CNS: postoperative delirium, cerebrovascular accident DVT: symptomatic DVT, asymptomatic DVT, Pulmonary emboli Infection: wound infection, prosthetic infection, need for major plastic reconstructive surgery or amputation.

Incidence of nausea and vomiting. Incidence of urinary catheterization. C. Economic outcomes: Length of hospital stay, direct health care costs, patient satisfaction

Primary hypothesis (null):

Perioperative analgesia provided by femoral and sciatic catheters, or by peri-articular wound catheters does not reduce the rate of combined serious outcomes compared with analgesia provided by peri-articular infiltration alone..

Secondary hypotheses (null):

  1. Perioperative analgesia provided by femoral and sciatic catheters or by peri-articular wound catheters does not improve functional recovery compared with analgesia provided by peri-articular infiltration alone.
  2. Perioperative analgesia provided by femoral and sciatic catheters, or by peri-articular wound catheters does not reduce the cost of delivery of care compared with analgesia provided by peri-articular infiltration alone.
  3. Perioperative analgesia provided by femoral and sciatic catheters or by peri-articular wound catheters is not improved compared with analgesia provided by peri-articular infiltration alone.
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ASA physical status 1-4
  • Ability to give informed consent
  • No contraindications to regional techniques
  • Ability to perform study related tests
  • Scheduled for primary Unilateral total knee arthroplasty

Exclusion Criteria:

  • Revision of arthroplasty
  • Allergy to local anesthetics and multimodal analgesic drugs
  • Contraindications to spinal anesthesia
  • Inability to perform study related procedures
  • Inability to give informed consent
  • Wheel chair bound
  • Pregnancy (positive pregnancy test on the morning of surgery)
  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: NCT01503528

Contacts
Contact: Sugantha Ganapathy, FRCPC 519 685 8500 ext 35115 sganapat@uwo.ca
Contact: Jonathan Brookes, FRCA 226 919 9424 ext - jonathan.Brookes@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre University Hospital Not yet recruiting
London, Ontario, Canada
Principal Investigator: Jonathan Brookes, MB ChB         
Sub-Investigator: Douglas Naudie, MD         
Sub-Investigator: Magdalena Terlecki         
Sub-Investigator: Jamie Howard, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Sugantha Ganapathy Professor, Director of Regional and Pain research, University of Western Ontario.
  More Information

No publications provided

Responsible Party: Sugantha Ganapathy, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01503528     History of Changes
Other Study ID Numbers: 18448, 18448
Study First Received: January 2, 2012
Last Updated: April 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
arthroplasty
wound
catheter
infusion
local
anesthesia
infiltration

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

ClinicalTrials.gov processed this record on October 23, 2014