Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Determination of Effectiveness of Periarticular Local Infiltration When Compared to Spinal Epimorph for Analgesia in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667445
• Other study ID #: 102837
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2012
• Last updated: April 27, 2015
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the contribution of spinal epimorph to patient's perioperative pain management in Total Knee Arthroplasty (TKA). This study is designed to determine whether spinal epimorph and its associated complications is a necessary addition to provide adequate analgesia given the multimodal approach to pain management. It is hypothesized that perioperative local infiltration with a cocktail of local and systemic analgesics will provide equal analgesia to patients who are given both local infiltration and spinal epimorph perioperatively.

Description:

This will be a randomized control trial comparing two patient populations obtained from patients who will receive a primary total knee arthroplasty at LHSC University Campus. Patient participants will be recruited and consented from the arthroplasty clinic and from the preadmit clinic at University Hospital. Both the patients and those measuring the primary outcome, namely, visual pain scales will be blinded to the experimental treatment received.

Patients will be randomized to receive either a spinal with epimorph (150ug) or a spinal with no epimorph at the time of their total hip arthroplasty. This is determined as a result of a computer generated randomization within blocks of 10 (every 10 patients there will be an even number of patients within each group). As each patient signs up they are given a consecutive study number which will determine which group they are assigned to. Note should be made that at the current time patients undergoing total joint arthroplasty may or may not receive epimorph preoperatively depending on their anaesthesiologist (personal communication with Sue Ganapathy) and so both treatment arms represent the current standard of care at LHSC. Again, spinal epimorph is currently being administered for total joint replacement, irregardless of whether or not this study is being done. It is an acceptable standard of care analgesic that is available to each anesthetist should they choose to use it. Many choose to use it as they feel it improves analgesia in patients undergoing total joint arthroplasty, which are recognized as very painful procedures (especially total knees). This is no different that one anesthetist preferring to use dilaudid for pain control and another choosing to use morphine. Both are within accepted standard of care guidelines and it is up to the individual staff to utilize the drug they feel is most beneficial. This decision is based on each individual consultant's interpretation of the available literature as well as their personal practice experience. I hope this justifies our study as we are not introducing any new treatment. Patients will receive spinal epimorph whether or not we conduct this study. As such, no formal study discontinuation rules are applicable. Both patient groups will receive medical treatment as required around the time of their procedure.

Both groups of patients will receive standardized preoperative analgesia including gabapentin (600mg), acetaminophen (975 mg) and naprosyn (500mg). Both groups will receive local anaesthesia in the form of local infiltration of the wound with a previously studied cocktail of morphine, ketoralac, epinephrine and ropivicaine. (3) Post operatively patients will remain on PCA until post operative day one and then will be changed to a standardized oral protocol including long and short acting narcotics on a PRN basis, acetaminophen (975 mg Q6h x 48hrs and then on a PRN basis), naproxyn (500mg BID x 7 days) and gabapentin (300mg BID x 7 days).

Postoperatively visual analogue pain scales will be recorded at 6, 12, 18, 24, 36 and 48hrs as well as at 1 week. Foley usage, oxygen usage, nausea/vomiting and use of antiemetics and antipruritics will also be carefully documented. Both patient groups will receive the standard post operative physiotherapy and will be discharged home with a prescription for the narcotic or analgesics that were providing them with suitable analgesia during their hospital stay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients must receive a primary total knee arthroplasty

Exclusion Criteria:

• Inability to have a spinal anaesthetic

• Intolerance to narcotic pain medication

• Inability to use a Patient Controlled Analgesia

• Revision total knee arthroplasty

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Epimorph
Patient to receive 150ug of Epimorph with Spinal anaesthetic. Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.
• Spinal analgesia
Patient to receive only Spinal anaesthetic (NO EPIMORPH). Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.

Locations

Country	Name	City	State
Canada	University Hospital, London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale for pain		1 week post-operatively	No
Secondary	patient report of nausea		48hours post-operatively	No
Secondary	patient report of pruritus		48hours post-operatively	No
Secondary	catheterization requirements		48hours post-operatively	No