Outcomes After Total Knee Joint Arthroplasty : A Comparative Study Using 3 Different Analgesic Techniques
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.
|Knee Joint Arthritis Knee Joint Arthroplasty||Procedure: Spinal anesthesia with periarticular infiltration Procedure: Femoral and sciatic nerve blocks Procedure: Periarticular infusions||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Outcomes After Total Knee Joint Arthroplasty : A Comparative Study Using 3 Different Analgesic Techniques|
- Primary outcome - incidence of global adverse events [ Time Frame: 3 months ]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.
- Perioperative pain [ Time Frame: Every 6 hours up to a total of 72 hours. ]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. ]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. ]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. ]These variables will be assesed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC score).
|Anticipated Study Start Date:||December 2017|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
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.
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):
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503528
|Contact: Sugantha Ganapathy, FRCPC||519 685 8500 ext firstname.lastname@example.org|
|Contact: Jonathan Brookes, FRCA||226 919 9424||jonathan.Brookes@lhsc.on.ca|
|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|
|Principal Investigator:||Sugantha Ganapathy||Professor, Director of Regional and Pain research, University of Western Ontario.|